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  • $160 hourly
    I am a Regulatory and Quality Consultant with expansive regulatory and quality experience with medical devices, OTC drugs, supplements, cosmetic products and surface cleaners. Over the last 20 years I've held various senior and executive level management positions within FDA and EPA governed companies. I started my career as an Environmental Analytical Chemist and I held my most recent position for 9 years as QA/RA Director for a Henry Schein specialty company, Ortho Technology, a worldwide distributor of orthodontic medical devices. I would love to help you get your new product to the market, as I have experience in regulatory requirements in over 50 countries! Some of my other specialties include technical writing to include SOPs (standard operating procedures), white papers, product submissions/dossiers, Organizational SOP writing (for any type of business), Overall Quality Management Systems that comply with ISO standards and various worldwide regulatory entities. I am well versed with FDA compliant advertising and can assist you with your device and drug label development and/or editing to ensure you are compliant to your jurisdiction. All of these skills require research, so yes, I am really good at that too! My forte and favorite thing is label compliance review! I can review your device, OTC drug, supplement, food, and cosmetic labels for compliance to US FDA, EU Directives, Health Canada and more! Check out my linked in profile for links to a few of the regulatory articles I have written recently. You can also search my name on the FDA website to find 510(k) evidence and other regulatory compliant reports that I have written and submitted.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Product Label
    Legal
    Drug Regulation
    Cosmetics
    Food & Supplements
    Label Compliance
    Medical Device
    Compliance
    Quality Assurance
    Legal Consulting
    Technical Writing
  • $325 hourly
    Hi, I am: ● A Los Angeles based, CIPP/US-certified attorney and consultant that can help your business navigate privacy and cybersecurity laws and regulations: General Data Protection Regulation (GDPR), California Consumer Privacy Act (CCPA) compliance, enterprise-wide implementation of data privacy best practices, and integration of privacy by design principles from the earliest stages of product development. ● A privacy attorney and DPO (Data Protection Officer) for a multi-national corporation with an annual revenue of ~$500 million. ● A former privacy attorney for a Big 4 broadcast television network. ● A former governance, risk, and compliance (GRC) consultant with experience in ISO/IEC 27001 gap analysis for a California based cybersecurity firm. ● A former member of a Seattle-based technology startup. ● The author of: Data Privacy and Compliance Guidebook for legal and cybersecurity professionals. I specialize in: ● Drafting and updating public-facing privacy policies and terms and conditions/use/service for websites, mobile applications, and IoT devices to address evolving business practices, including policies of multinational organizations with websites for multiple verticals. ● Drafting supplemental technology agreements, including EULAs for mobile applications, HIPAA Business Associate Agreements, and more. ● Advising executive, marketing, IT, and business operations teams on technology-related legal, regulatory, and compliance risks facing their organizations. ● Compliance with US State and federal privacy and data management laws and standards including the Children’s Online Privacy Protection Act, Gramm-Leach-Bliley, HIPAA, CAN-SPAM, the Telephone Consumer Protection Act, the Fair Credit Reporting Act,the Payment Card Industry Data Security Standard, and California’s Shine the Light law and Online Privacy Protection Act. ● Compliance with international privacy regulations, including the GDPR, and legal requirements for cross-border data transfers, including preparation and implementation of standard contractual clauses (Controller to Controller and Controller to Processor). ● Advising on due diligence for, and negotiation and drafting of terms for, vendor agreements involving the sharing of sensitive information. ● Overhaul of business procedures and policies. This includes employee handbooks and training materials on compliant management of personal information, incorporation of privacy by design principles and the establishment of data governance and cybersecurity-compliant best practices. I provide white-glove expertise and select potential clients with care. Having worked with corporate clients ranging from single-member startups to Fortune 500 companies, I am confident I can provide on-point solutions for your business needs. For more information on my background and skillset, please find me on LinkedIn. Thank you for stopping by, Raj
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    Privacy Law
    Certified Information Privacy Technologist
    Privacy Policy Writing
    Privacy Policy
    California Consumer Privacy Act
    Privacy
    Terms & Conditions
    Project Risk Management
    Contract Law
    Legal Consulting
    Corporate Law
    Data Privacy
    State Bar of California
    Startup Consulting
  • $345 hourly
    Top Rated Plus Attorney on UpWork with 100% Job Success! I am a California-barred attorney specializing in business needs. My areas of expertise include corporate formation, contract law, regulatory compliance and licensing, general corporate law, and employment law. I truly enjoy getting to know my clients, whether they are big businesses, small start-ups looking to launch, or individuals needing legal guidance. Some of my recent projects include: -drafting business purchase and sale agreements -drafting letters of opinion for small business loans -creating influencer agreements -creating compliance policies and procedures for businesses in highly regulated industries -drafting service contracts -advising on CA legality of hiring gig workers including effects of Prop 22 and AB5 -forming LLCs -drafting terms of service and privacy policies -reviewing employment contracts I received my JD from UCLA School of Law and have been practicing for over six years in this area. I’m an avid reader and writer and believe those skills have served me well in my practice. I also complete continuing education courses regularly to ensure I am up-to-date on best practices for my clients. I pride myself on providing useful and accurate legal advice without complex and confusing jargon. I look forward to learning about your specific needs and helping you to accomplish your goals. Please reach out to learn more about my process and see if we are a good fit!
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Contract Negotiation
    Contract Law
    Legal Assistance
    Document Analysis
    Business Law
    Legal
    Legal Research
    Contract Law
    Licensing
    Corporate Law
    State Bar of California
    Compliance
    Employment Law
  • $45 hourly
    I am a Product Safety Specialist having extensive experience in the field of Product Certification(CE marking/CE Certification/regulatory compliance). If these are the services that you require, I can promise that you are in safe hands for an end to end solution right from carrying out a Product Analysis, preparing a Conformity Assessment procedure, compiling a Technical File leading to drafting the Declaration of Conformity. About myself, I am a Mechanical Engineer with an MBA (Operations) and a Bachelor in Law. I have worked with several Manufacturing, Consulting and Certification agencies during my 30 years tenure. I am very knowledgeable about the various European Directives, Standards & conformity assessment procedures, Risk Assessment studies etc., I support various clients for products falling under Machinery, Low Voltage, Electromagnetic Compatibility, RED, ROHS, Construction Products Regulation and others. Also familiar with other Directives such as ATEX, PPE, PED, Medical Device etc., I have worked with Certification Bodies such as Bureau Veritas, TUV Rheinland and TUV Nord for a span of 17 years. I am therefore confident of supporting my clients for their various requirements. I have supported companies for Certification of : CNC Machines, IoT products, Consumer & Electronic products, Beverage Dispensers, Control Panels, , Material Handling Equipment, Data Loggers, 3D Metal Printers, Gear hobbing and grinding machines, Card sorters, Sheet Metal Press, Motors, Pumps, Alternators, Transformers, Test Rigs, Hydraulic Power Packs, Glass Lifting Machines, Automatic Voltage Regulator, Valves and many more. I am very active on Upwork and have rendered services for my Clients located in USA, Australia and various parts of Europe. During my career, I have rendered services to Globally renowned companies such as ABB, Bosch, Liebherr, Millipore, Biozeen, Atlas Copco, Sandvik, Weir Group, Nagel Special Machines, Yuken, Schenck Group, Mann & Hummel, Murugappa Group, Micromatic Grinding Group, Triveni Engineering and many more.
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    Risk Analysis
    Technical Documentation
    Regulatory Intelligence
    Product Documentation
    Compliance
    Legal Consulting
    Compliance Consultation
    Product Label
    Safety Assessment
    Medical Device
    Risk Assessment
    Label Compliance
    Product Listings
  • $75 hourly
    Management of all import processes including HTS, ACE Entry, ADD/CVD, FTA's and PGAs. Internal Customs for Tariff reviews, bond sufficiency, POA approval and Port of Dallas audits. Maintain relationships with International Agents to meet CTPAT Compliance standards. Customer visits and problem resolution. Expertise in 3PL freight forwarding.
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    Trade Law
    Third-Party Logistics
    Compliance Consultation
    Import Procedure
  • $50 hourly
    With a Master Degree in Nutrition and Food Science from the University of Huddersfield and BSc in Sports, health, exercise and nutrition from the University of Leeds combined with over 8 years experience in food manufacturing means I am an excellent resource in helping you meet your food labelling, legal and nutrition needs. I am tenacious, hardworking and dedicated which helps me deliver excellent results for my clients. I pride myself on my ability to analyse problem solve, interpret and disseminate information in easily understood terms. I look forward to supporting you and your business.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Label Compliance
    Product Development
    Label & Package Design
    Food & Supplements
    Nutrition
    Legal Consulting
    Quality Control
    Recipe Development
    Recipe Writing
    Manufacturing & Construction
  • $85 hourly
    I am a Certified Information Security Auditor (CISA) . I am an expert leading SOC 1/SOC 2 engagements and it's variations, HIPAA and HiTrust. I have extensive experience leading compliance design and implementations in preparation for audit engagements including both evidence gathering and report reviews. I have worked both in the internal audit and external audit sectors for one of the largest public accounting firms in the US. I work with businesses of varying sizes from start-up to Cloud 100. I am passionate about "right sizing" business process to narrow down the focus areas to drive efficient implementation of controls on an ongoing business. If you have any technology compliance needs or require answers to general compliance questions or guidance feel free to reach out to me.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Business Continuity Plan
    Information Security Audit
    Security Infrastructure
    Information Security Governance
    Policy Writing
    Compliance
    GDPR Compliance Review
    SaaS
    SOC 1 Report
    HIPAA
    Compliance Consultation
    IT Compliance Audit
    Risk Assessment
    Sarbanes-Oxley Act
  • $200 hourly
    Hi, I'm Jeff and I am an experienced BSA/AML compliance consultant who most recently served as Chief Compliance Officer at bitFlyer USA, where I led the Legal, Regulatory Affairs, Compliance, and Risk departments. I've built multiple AML programs from the ground up, and have worked in almost every area of payments compliance for various cutting edge financial services including Google and Coinbase. I am currently available for short to medium term consulting work for money transmitters and/or money services businesses. If you are looking for a BSA compliance officer/MLRO/CCO, I can fill that role as well, please contact me for specific rates.
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    Blockchain
    Regulatory Intelligence
    Bitcoin
    Cryptocurrency
    Compliance Consultation
    Finance & Accounting
    Compliance
    FinTech Consulting
    Anti-Money Laundering
    Internal Control
  • $125 hourly
    Greetings! I am a certified Regulatory consultant with over 10 years of experience managing pharmaceutical, biologics, medical device (including SaMD), and combination product projects. I specialize in helping companies navigate the complex landscape of FDA regulations to ensure that products are safe, effective, and compliant. I'm Top Rated Plus with a 100% Job Success score. What I Offer: • Expertise in compiling, reviewing, and submitting FDA applications like 510(k)s, INDs, and NDAs. • Human factors engineering and usability engineering expertise. • Extensive experience in quality assurance, cGMP, and ISO 13485. • Conducting internal audits to ensure FDA compliance. • Risk assessment and mitigation strategies. • Regulatory documentation and label review. • Liaison between your team and regulatory agencies. Why Choose Me: • Proven track record of successful FDA submissions. • Strong project management skills to ensure timely project completion. • Excellent communication skills, both written and verbal. • Current with the latest FDA guidelines and updates. • Passionate about bringing safe and effective products to market. I'm flexible and reliable, and I pride myself on meticulous attention to detail. My ultimate goal is to help your company mitigate risks and expedite the time-to-market for your products. I'm looking forward to bringing my expertise to your project!
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Internal Auditing
    Usability Testing
    Human Factors Analysis
    Compliance
    Pharmaceutical
    Continuous Improvement
    Process Improvement
    Quality Assurance
    Medical Device
    Elearning
    Business Analysis
    QA Management
    Regulatory Intelligence
  • $70 hourly
    Hello and thank you for visiting my profile! My Key Services: ✅ GDPR compliance ✅ CCPA/CPRA compliance ✅ Privacy Strategy Development ✅ Your Data Protection Officer (DPO) ✅ Gap Analysis ✅ Privacy Compliance Audit ✅ Privacy Policy & related documentation ✅ PIA & DPIA ✅ Data Processing Agreements (DPAs) ✅ Privacy By Design & By Default ✅ Data Governance & Customized Legal Solutions ✅ Data Subject Access Requests (DSARs) ✅ Cross-Border Data Transfers ✅ Privacy Due Diligence for M&A ✅ Regulatory Compliance ✅ ISO/IEC 27001/27701 ✅ NIST & SOC2 cybersecurity frameworks ✅ IP & IT Law ✅ Contract Law About Me: My name is Iurii, I'm a European and International Business Lawyer (LL.M), a Privacy Professional (CIPP/E), and a certified translator from English to Ukrainian/Russian and vice versa. Being always hard-working, and highly motivated I'm glad to provide you and your business with high-quality legal services based on my qualifications and legal work experience. Since 2014 I have been practicing law in several particular spheres (data protection and privacy law, intellectual property law, information technology law, and corporate law) in all three Ukraine/EU/USA jurisdictions and I always adhere to the principle: nobody can be the expert at everything. That's why I consider myself as a niche professional who renders equally professional services in specified areas of law. In 2014 I obtained a Master's degree in International law at Taras Shevchenko National University of Kyiv, Institute of International Relations which for many years remained one of the top-ranking universities in Ukraine and is one of the top world universities (according to QS World University Ranking 2017). Moreover, at the same time, I obtained a diploma in translation from English. While practicing law in several Ukrainian top-rated law firms (according to the legal500.com) I gained invaluable legal experience in International arbitration, mediation and protection of intellectual property rights. During 2015-2017 I had an opportunity to study International and European Business Law at Vienna University (Austria) where I obtained the necessary knowledge and qualifications that allowed me to practice law worldwide. If you are interested in my services please do not hesitate to contact me and I will do my best in order to help you and your business!
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Privacy Law
    Corporate Law
    Privacy Policy Writing
    Data Protection
    Contract Law
    Legal Translation
    Policy Writing
    GDPR
    English to Ukrainian Translation
    Legal Consulting
    Intellectual Property Law
    English to Russian Translation
    Data Privacy
    Policy Analysis
  • $115 hourly
    The "Idea to Item" guy, I am your Director of Engineering for Hire! Director of Engineering for start ups, I have worked primarily in FDA Class I medical devices and robotics, focusing on human gait and movement. Prior experience includes managing a multi disciplinary team of engineers for design and integrations of battery operated software controlled devices, with multiple products successfully brought to market including computer controlled prosthetics, Markerless motion capture gait labs and automated analysis software, and recently a hands free crutch. Capabilities include - Prototype design and test in traditional, 3D printed, and composite materials - Testing to international and self selected standards and creation of a Declaration of Conformity - Initial clinical trials - Regulatory and Intellectual Property - Production launch and manfacturing Scale-Up - Engineering Support in market acceptance phases.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Engineering Management
    Hydraulic Engineering
    Medical Device
    Hardware Troubleshooting
    Engineering Simulation
    Engineering Design
    Intellectual Property Consulting
    Finite Element Analysis
    SolidWorks
    Mechanical Engineering
    Product Development
  • $30 hourly
    Compliance Officer and Paralegal specialized in regulatory compliance, contract drafting, data protection laws ( GDPR / CCPA / DPA ), AML & KYC policies. Around 10 years of experience in the financial, fintech, payments, commerce and healthcare fields within International Organizations. - Draft Contracts and Agreements tailored to your business - Partnership and Shareholder Agreements - Policies and procedures, SOPs - Regulation research - Licenses and permits application preparation and submission - Interaction with regulatory authorities - GMP license / TGA medicine manufacturing requirements
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Data Protection
    Terms & Conditions
    Contract Drafting
    GDPR
    Non-Disclosure Agreement
    Compliance
    Contract Management
    Corporate Law
    International Law
    Anti-Money Laundering
    Partnership Agreement
    Data Privacy
    Legal Research
  • $100 hourly
    Do you have an idea for a new cosmetic or personal care product that is natural, vegan, organic, green, or botanical, and do you need help formulating it so that it meets the highest quality requirements and has the best possible economic effectiveness? You've come to the perfect person to get your United States NOP, ECOCERT, COSMOS, or ACO certification, among other certifications. I am a member of the Society of Cosmetic Chemists (SCC), the International Federation of Societies of Cosmetic Chemists (IFSCC), and the American Institute of Chemical Engineers (AIChE). In addition, I am a "Top-rated Plus" research and development cosmetic chemist and cosmetic product formulator who specialises in Natural/Vegan/Organic/Green products. 💫Qualification Cosmetic Science, Chemical Engineering, and Science Laboratory Technology are my academic specialties. 💫Formulation of Cosmetics If you have an idea, I am able to design a prototype for the product line in accordance with the specifications and goals that you have provided. The approach entails the creation of the formula as well as its optimization, the selection of the raw materials, process architecture, and the manufacturing method. I will develop natural, vegan, organic, and eco-friendly products for skincare, oral care, and hair care, in addition to a broad variety of essential cosmetic and personal care products. New product innovations rely on the most effective anti-aging and skin whitening ingredients now available on the market, many of which aren't widely used. As a researcher, I employ these rare compounds in my new product developments. To help clients with the patenting process, I've sent 15 of them to patent lawyers after we were successful in getting patents for some of our unique biotechnological formulations in the green, organic, natural, and vegan cosmetic and cosmeceutical markets. Since I have my own laboratory, I am able to successfully develop cosmetic products that are in compliance with all of the regulations set by the EU, the TGA, and the FDA. I have more than ten years of expertise in the development of new products, notably in the field of cosmetics, as well as in the formulation of new products and the procedures involved in chemical manufacture. My expertise in quality assurance and quality control extends to a broad variety of areas, including chemical analytics. 💫Product Development/Management In addition to being a formulator and a cosmetic chemist, I am also prepared to work as a thorough product manager and developer to put the concept of a cosmetic line into reality. My high-level duties as a product manager include taking care of the following, among other things: ✔ The picking and choosing of the products that will become part of the cosmetic brand. ✔ Getting in touch with manufacturing companies in order to have the products manufactured by them. ✔ Finding dropshipping companies to use for exporting the products. ✔ Execute the branding and packaging. The scope of my work spans through: ✔ Research and Development (R&D)/Formulation ✔ Regulatory Compliance ✔ Quality Assurance (QA)/Stability Testing ✔ Packaging ✔ Product Lifecycle Management (PLM) ✔ Contract Manufacturing ✔ Good Manufacturing Practices (ISO 22716) Everything I do revolves around your requirements and preferences. As for me, I'll keep at it until you're completely satisfied, too. Please feel free to make an offer if you think I can help you with your project.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Laboratory Equipment Skills
    Cosmetic Raw Materials
    Chemical Engineering
    Contract Manufacturing
    Good Manufacturing Practice
    Cosmetic Regulation
    Reverse Engineering
    Beauty & Personal Care
    Skin Care
    Product Development
    Technical Writing
    Cosmetics
    Chemistry
    Product Formulation
  • $80 hourly
    A seasoned IT and Compliance Professional with 20+ years experience in IT Operational Systems, Information Security Governanceand Compliance. I have been working as an ISO Consultant and Auditor for 8 years and manage projects for preparation of ISO 27k1 compliance, Data Governance & Compliance or supporting organisations in creating better Security Policies or Information Management Awareness. Strengths: I am good at adapting to situations in any circumstance, and I remain calm under pressure to ensure we don't lose focus on the end game. I am a great team player, both onsite and remote, and look to support the team, not stand out against the crowd. No work is "above" or "beneath" me; I roll my sleeves up and get to work. Weaknesses: I am susceptible to perfecting my output, which sometimes causes me to overthink my delivery. Projects: I have recently completed projects related to GDPR, legal preparation on GDPR Compliance for Policy and Procedures, data protection, analysis of information and how it is transported within client organizations, and risk assessments on large scale projects for European Institutions in Intellectual Property and Financial Sectors. Achievements and Education: I have a Masters in Business Administration, and I operate my company from Prague, Czech Republic. I employ a humble 16 staff who all work in specific areas around Information Security and GDPR / Data Protection. It has been an extremely rewarding struggle, but a challenge is not fraught without difficulties :-) I am CISSP Certified, GDPR P Certified, ISO 27001 Certified (looking to become Auditor) with a broad knowledge of public speaking ( I have been a speaker for conferences in Eastern Europe on InfSec). I also lecture at King Charles University Post Grads in Prague, Czech Republic, because I believe that the key to identifying good talent is to interface at the source of discovery, which ultimately begins High School / College / University. I am also working to become the Rugby coach for under 21s rugby in the Czech Republic :-)
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    International Law
    GDPR
    Data Protection
    Security Analysis
    Security Infrastructure
    Compliance Consultation
    Legal Writing
    Information Management
    Data Privacy
    Compliance
    Risk Assessment
    Contract Drafting
    Legal
    Contract Law
    Information Security
  • $120 hourly
    Over 15 years of experience with medical device and pharmaceutical regulatory compliance and quality systems. Areas of expertise include: -21 CFR 820 (Medical Device GMP) -21 CFR 211 (Pharmaceutical cGMP) -21 CFR 111 (Dietary Supplements) -ISO13485: 2016 (Medical Device Quality Systems) -Internal auditing -FDA responses/corrective actions for 483s/Warning Letters -Gap assessment and remediation -Writing and revising policies and procedures for quality system compliance -Regulatory and claim substantiation reviews of labeling and marketing materials -Design control regulatory team member -Risk assessments -Regulatory due-diligence for acquisitions -FDA preparedness training -Supplier management -Complaint management and reporting to regulatory agencies -3rd party audit responses and CAPA development -Recall coordinator -UDI implementation -California Prop65 compliance -State Board of Pharmacy licensure for manufacturers/wholesalers -NAFTA COO Certifications, VA Letters of Supply, Conflict Minerals Surveys, FDA Certificates for Foreign Governments applications -FDA Medical Device Establishment registration and Device Listings -Deviation investigation and risk assessment/mitigation -ABC (American Board for Prosthetics and Orthotics) Facility Accreditation/Medicare Supplier Accreditation (developed quality system to ensure compliance; lead audits) Proficiency in the following: -Trackwise -Salesforce -Word -Excel -Powerpoint -Access -Adobe Specializing in the development of lean, efficient and compliant solutions to address FDA and international regulatory requirements.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Supplier Development
    Policies & Procedures
    Procedure Manual
    Document Management System
    Project Risk Management
    Document Review
    Pharmaceutical Industry
    Internal Auditing
    Medical Device
  • $44 hourly
    I have almost 25 years of legal, business, and administrative experience with an MBA and ABA approved Associate's Degree in Paralegal studies. My services include: • Preparing, filing and maintaining company licensing • Drafting, filing and managing various business entity documents for corporations, LLCs, and other business entities with State agencies. • Drafting, filing and maintaining corporate records, including resolutions, minutes, etc. • Producing documents related to the development and implementation of corporate policies and templates • Providing contract support, including planning, collaboration, negotiation, and execution • Conducting regulatory impact analysis on applicable laws My skills include: • Extremely reliable, responsible, and deadline driven • Detail oriented and analytical • Resourceful and creative • Excellent research skills using Internet and databases • Advanced computer skills and type an average of 65 WPM
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    Cryptocurrency
    Legal Assistance
    Project Management
    Legal Writing
    Corporate Law
    Licensing
  • $220 hourly
    Medical devices are my work and my passion. I can help you with product development from initial concept and clinical research to regulatory submission and manufacture. My skills and projects include R&D, Product Development, Design Control, Quality Management Systems Administration, Verification & Validation activities, Project Management, Material Selection, Vendor Selection, Biocompatibility Testing, MRI Safety Testing, UDI Compliance, and more! As additional services I can provide CAD modeling, 3D printing and fabricated functional prototypes.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Engineering Design
    Rapid Prototyping
    Project Management
    Engineering Management
    Engineering
    Medical Device User Manual
    Medical Device
  • $90 hourly
    Over 8 years experience in Regulatory Affairs, V&V and technical submissions for a range of medical devices, including orthopaedics, active implantable and novel, high-risk electromechanical systems. Responsible for authoring several 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, biocompatibilty reporting, process validations, labeling and packaging etc). Similarly, have authored several technical files and design dossiers for CE marking of Class IIa, IIb and Class III devices. Handled all subsequent follow-ups and questions from Notified Bodies, including on-site audits from both the FDA and BSI. Participated in pres-sub activities with the FDA for novel high-risk implants in the design phase, to establish regulatory pathway to First In-Human trials and subsequent PMA. Achieved and maintained registration of products in a range of jurisdictions including EU, US, Canada, Australia, Israel, Chile and Japan. Familiar with the application of a range of standards including ISO 13485, ISO 14971, IEC 60601, FDA 21 CFR Part 820, as well as upcoming changes in the new EU MDR. Well versed in the development and lodgement of Regulatory Files, and can complete activities such as literature searches, clinical evaluations ,predicate device comparisons, development of SOP's and other QMS documentation, as well as validations for processes such as sterilization (gamma and EtO), packaging, and Human Factors Engineering studies. I look forward to working with you!
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Medical
    Drug Regulation
    Medical Device
    Technical Writing
    Biotechnology Regulation
    Quality Control
  • $20 hourly
    Are you in need of an experienced Anti-Money Laundering (AML) Specialist and regulatory compliance consultant with 11+ years of experience in AML compliance to help your business navigate complex regulations and stay compliant with relevant laws? As a Certified Anti-Money Laundering Specialist (CAMS) with extensive experience in developing and implementing AML, CFT, and KYC policies and procedures, as well as conducting AML independent audits, AML internal auditing, and ensuring regulatory compliance, I offer a diverse and comprehensive range of services to help your organization mitigate risks, maintain regulatory compliance, and protect against fraud and financial crime. In my role as an AML expert, I bring a wealth of knowledge and practical expertise to assist your business in navigating the complexities of anti-money laundering, countering the financing of terrorism, and know-your-customer practices. My specialized skills in AML independent audits and AML internal auditing allow me to objectively assess your organization's compliance framework and identify areas for improvement. By availing my services, you can rest assured that your AML, CFT, and KYC policies and procedures will be in line with the latest regulatory requirements and industry best practices. I am dedicated to supporting your organization in establishing robust controls and processes to prevent financial crimes and safeguard your reputation. Here are some areas where I can assist you: KYC/KYB Onboarding Transaction Monitoring and Sanction Screening Suspicious Activity Reporting Developing and Implementing AML and KYC Policies and Procedures Conducting AML Risk Assessments and Gap Analyses Performing AML Investigations and Due Diligence Checks Designing and Delivering AML and Compliance Training Programs Conducting Compliance Audits and Reviews Providing Regulatory Advice and Guidance Regulatory Compliance Assessment Regulatory Compliance Training AML Audit Support Ongoing Compliance Support I have experience working in the following industries: Banks Financial Institutions Money Services Businesses (MSBs) Cryptocurrency Exchanges Payment Platforms Remittance and Money Transfer Services Regtech (Regulatory Technology) Firms Cross-Border Payment Service Providers Digital Asset Exchanges and Trading Platforms I have experience working in the following jurisdictions: United States (US) United Kingdom (UK) Canada United Arab Emirates (UAE) Saudi Arabia European Union (EU) African Region Asian Region
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Customer Service
    Compliance
    Data Analysis
    Anti-Money Laundering
    Training Presentation
    Risk Assessment
    Business Development
    Compliance Training
    Risk Analysis
    Marketing
  • $20 hourly
    Jared is a qualified, licensed attorney, engaged in the practice of law for the last over 8 years. He holds an Bachelor of Laws Degree and a Postgraduate Diploma in Law. He is conversant with the laws and legal procedures applicable to various jurisdictions in the USA, the UK, Australia, and Canada. He has exceptional drafting skills, coupled with the good command over English language and an eye for detail. Jared has expertise in non-litigation work as well as litigation work, and can provide the following legal services: 1.) Review & Drafting of all kinds of Contracts & Agreements; including, but not limited to: ======================================================================= • Master Service Agreement (MSA) • Statement of Work (SOW) • End-user License Agreement (EULA) • Software as a Service (SaaS) Agreement • Marketing Services Agreement • Professional Services Agreement • Consultancy Agreement • SEO Service Agreement • Franchise Agreement • Asset Purchase Agreement • LLC Membership Interest Purchase Agreement • Partnership Agreement • Joint Venture Agreement • Business Development Agreement • Distribution Agreement • Reseller Agreement • Employment Contract • Company Property Rental Agreement • Independent Contractor Hiring Agreement • Share Transfer Agreement • Share Purchase Agreement • Shareholders’ Agreement • IP/Copyright Assignment Agreement • Publishing Agreement • Real Estate/Property Sale/Purchase Agreement • Lease Agreement • Loan Agreement • Confidentiality & Non-Disclosure Agreement (NDA) 2.) Review & Drafting of Legal Documents; including, but not limited to: ======================================================== • Title/Conveyance Deed • Mortgage Deed • Power of Attorney • Corporate Resolutions • Corporate By-laws • Promissory Note • Affidavit • Authorization for Release • Disclaimer • Website Terms & Conditions and Privacy Policy • Product Warranty • Will • Trust Deed 3.) Intellectual Property Law. =========================================================== • Advising on Copyrights, Patent, Trademark law. • Drafting and Reviewing Copyright, Patent, Trademark applications. 4.) Review & Drafting of Litigation Documents; including, but not limited to: =========================================================== • Legal Notice/Lawyer's Letter, Cease & Desist Notice • Plaint/Complaint, Statement of Claim • Answer to Plaint/Complaint, Written Statement of Defence • Motion, Response in opposition to Motion Contract Law, Property Law, Tax Law, Intellectual Property Law, Corporate & Commercial Law, Insolvency Law and Securities Law among other areas of Law. 5.) Legal audits and compliance. =========================================================== Please feel free to reach out to me for any urgent legal support. I am available around the clock to offer quality legal work and support.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Governance, Risk & Compliance Software
    Trademark
    Management Consulting
    GDPR Compliance Review
    Contract Law
    Litigation
    Legal Writing
    Mediation
    Alternative Dispute Resolution
    Legal Research
    Corporate Law
    Contract Drafting
    Non-Disclosure Agreement
    Legal Consulting
  • $50 hourly
    Owner of HIM Experts LLC offering IT risk assessments and audits. HIM consulting focusing on privacy and security, virtual compliance officer services, and other business consulting needs. I am a RHIA (Registered in Health Information Administrator) and CHPS (Certified in Healthcare Privacy and Security) credentialed professional through AHIMA. I have been running my own business since 2019. I have 3 years of management experience as a HIPAA Security and Privacy Officer. Over a decade of of overall experience in the healthcare industry specializing with Business Associates in the areas of medical billing, coding, chart development, etc. Experienced in IT audits/ risk assessments utilizing various frameworks such as SOC 1 & 2, NIST CSF, ISO 27001, PCI, and CMMC frameworks. Successfully ran an IT security program from user end technologies to overall framework and policy and process creation as a Privacy and Security Officer for a business associate with clients in over 40 states.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Healthcare IT
    Information Security Awareness
    Network Security
    HIPAA
    Compliance Training
    Compliance Consultation
    Vendor Management
    Security Analysis
    IT Compliance Audit
    Information Security
    Compliance
  • $65 hourly
    Professional Summary Executive leader in healthcare and mental health industry with 15 years of experience in grant writing, training and program development. Procedure and policy creation with successful implementations in the areas of risk management, federal compliance, fraud and abuse.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Healthcare Management
    Consultation Session
    Life Coaching
    Procedure Manual
    Voice-Over
    Training & Development
    Policy Development
    Mental Health
    Nonprofit Organization
    Compliance Consultation
    Social Work
    Policy Writing
    Fraud Mitigation
    Nursing Management
    Grant Writing
  • $60 hourly
    Over 10 years of Regulatory Compliance experience in categories like electrical and electronic products, wireless, mechanical equipment, medical device, toys, automobiles, softline, buildings, food, chemicals for clients including manufacturers, innovators, retailers, importers, exporters, marketers, surveillance to get national, regional or global Market Access at a cost effective and time efficient manner. Can provide design review, documentation screening, CE marking, Brexit transition UKCA marking, safety testing, performance validation, compliance advice, product certification via desktop consultation or outsourcing and managing package services. Accept materials in both English and Chinese and can offer Technical Translation bothways. Aim for initial response within 48hrs for a product review proposal. Further testing and certification work needed if any will be subject to the client’s query. As I'm UK based, if you are looking for an Authorized Representative for UK market and UKCA conformity, feel free to discuss the setup. I am also a Global Multi Assets Investment Consultant. This might not be the most relevant platform, but should anyone need consultation or have a mandate to achieve, please feel free to contact me. Specialties • Specialise in CE, UKCA, CB, UL, FCC, ETL, MET, EPA, RoHS, REACH, PTCRB, CCC, PSE, BEAB, GS, SASO, INMETRO, NOM, SABS, KC, TISI, RCM, IMDA, SIRIM, ICASA, WEEE, Zigbee, LoRa Alliance, HALT, IP, EcoLabel, LEED, EnergyStar, ESOS, GFSI, Allergy UK, ESQ, Environmental Claim Validation programs, wireless, consumer and industrial product Standards such as EN, IEC, UL, CISPR, BSI, GB, KN, TISI, Ozone ID-214, Optical Radiation, GHS, ISO 14001, ISO 50001, ISO 26000, OHSAS18001, FSSC22000. • Appliances, Lighting, Electronics, Telecoms, Toys, Machinery, Consumer Goods, Hardware, Softline, Furniture, Consumables, Medical Devices, Industrial etc • English (Native), Mandarin (Native), Cantonese (Intermediate). ***Profile Updates*** I have been involved in the international volunteer work supporting COVID-19 emergency sincethis January and have gained abundant experience and resources to assist almost every region who requires faster delivery of anti-epidamic supplies including Medical Device, Personal Protective Equipment, Detection and Monitoring System (e.g. certified Viral Nucleic Acid Extraction Kit for SARS-CoV-2). Please read below my service scope on the product import/export side. I can also help with Coronavirus physical and/or mental health support and translations. - Regulatory compliance review, testing assessment and certification for Medical Device, Personal Protective Equipment, detection and monitoring equipment; - Provide compliance solutions for products or manufacturers in need of certificates for the targeted market, project management of safety testing to obtain third-party reports; - Search and connect buyers or organizations who wish to make donation of any anti-epidamic supplies, investigate local importation process and requirements; - Arrange air/sea freight, customs filling and clearance; - Clarify common questions, help with supply chain liaison, identify and evaluate factory if any production capacity challenge. ******
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    English to Chinese Translation
    Legal Consulting
    Market Research
    Photo Editing
    International Business
    Property Management
    Investment Research
    Regulatory Intelligence
    Chinese to English Translation
    Translation
  • $40 hourly
    🎯 Expert Vetted + Top Rated Plus I offer Complete CFO Services. The goal is to become a one stop finance, business planning and accounting solution for your company. Mission Statement: Partnering with clients to drive growth, profitability, and success I have graduated from Manchester Business School, England (A Top 20 Global B School) I am an Alum of IIM Bangalore and SRCC Delhi (India's top B schools). I also secured National Rank 14th in CA CPT Exams (CPA equivalent). I manage Efincatalyst, with a focus on offering Business and Financial Consulting. We also offer white label solutions to consultants, coaches, lawyers and bankers. Highly advanced Finance and Excel modeling skills, coupled with my forte in building complex forecast models enable me to perform investment bank grade analysis, leading to professionally prepared financial projections and statements. I am also an expert in creating pitch decks, business plans and corporate presentations targeted at bankers and investors. I am also joined by my Partner- Jain, a Financial Consultant with expertise in offering CFO solutions, financial modeling, pitch decks, ICOs, Crypto, and investor fundraising. He is a CA (CPA equivalent), CFA L2 Candidate and has studied at Cambridge University (Sydney Sussex College), England. Software Stack Proficiency: MS Excel, Google Sheets, Tableau, PowerBI, QuickBooks, Xero, Adaptive Insights, Workday, NetSuite, Zoho Books, Zoho Analytics, Fathom and MS Suite. ✅ Proficient in: ---------------- - Fundraising Business Plans And Investor Presentations - Pitch Decks and Pitch Books - Business Plan Writing - Investment Research - Financial Research, Planning, Analysis - Data Visualization and Analytics - Memorandum for Sale Presentation (Investor Memorandums) - Valuation Report and Analysis - Accounting and Financial Reporting - Financial Forecasting - FP&A SaaS Ops - M&A LBO Modeling - Real Estate Modeling - Investor MIS KPI Dashboards ✅ Working With Me Can Be Beneficial In The Following Ways: -------------------------------------------------------------------- - Excellent Written and Spoken English Skills. (Published Writers) - ~60 Hours/week availability - Committed to finish projects in agreed deadline - Flexible working hours as per customized client timings - I provide project/job updates on a regular basis so that you can track the progress. - I will help you in all the different stages of the project. - I have traveled extensively across the United States, Europe and GCC. - 50% of our clients are from US and Canada, 30% from Europe and Middle East - We are happy to take both long term and one-off projects. We have been working with some clients for over 5 years on the platform. - We focus on supporting Startups, SMBs and Corporates Our USP: We love our profession. We love reading, talking and thinking about businesses and how we can empower their growth. We think of every project as a puzzle to be solved in a particular budget and timeline while meeting Business Owner/CXO objectives. Please feel free to have a no obligation call to understand if we can add value to your business.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Business Plan
    Financial Accounting
    Investment Research
    Financial Management
    Legal Consulting
    Bookkeeping
    Budget Management
    Business Analysis
    Business Valuation
  • $75 hourly
    Welcome to my Upwork profile! I am a Certified Information Privacy Professional with a strong background in worldwide privacy laws and regulations, holding the esteemed CIPP/E and CIPM certifications by the International Association of Privacy Professionals (IAPP). Unlocking the Power of Data Privacy, Compliance, and Security. About Me 🔒 Certified Data Privacy Professional: - GDPR (General Data Protection Regulation) - CCPA (California Consumer Privacy Act) - HIPAA (Health Insurance Portability and Accountability Act) 🛡️ Security Framework Expertise: - ISO (International Organization for Standardization) - SOC (System and Organization Controls) My Mission To empower organizations with robust data privacy, compliance, and security solutions that safeguard data assets, enhance trust, and drive sustainable growth. Areas of Expertise 🌐 GDPR Compliance - Comprehensive understanding of EU data protection regulations. - Crafting strategies for GDPR readiness and compliance. 🌟 CCPA Expertise - Navigating the intricacies of California's privacy law. - Ensuring your organization meets CCPA requirements. 🏥 HIPAA Compliance - Protecting sensitive healthcare information. - HIPAA-compliant data management and security. 🔐 Security Frameworks - Implementing ISO and SOC standards for data security. - Strengthening your organization's security posture. Why Choose Me? ✨ Proven Track Record - Successfully guiding organizations through complex compliance challenges. 🤝 Tailored Solutions - Customized strategies that align with your unique business needs. 🚀 Future-Ready Approach - Staying ahead of evolving privacy regulations and security threats. 💡 Thought Leadership - Active participation in industry discussions and continuous learning. My Credentials: - Certified Information Privacy Professional - Europe (CIPP/EU) by IAPP: - Certified Information Privacy Manager (CIPM) by IAPP: - OneTrust Privacy Management Professional: IAPP Membership: I am an active member of the International Association of Privacy Professionals (IAPP), demonstrating my commitment to staying at the forefront of privacy trends and regulations. Let's Connect! If you're seeking a trusted partner to navigate the complex world of data privacy and governance, I'm here to assist. Let's collaborate to achieve your goals and protect what matters most - your data and your reputation.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Data Processing
    Incident Response Plan
    Contract Drafting
    Data Protection Act
    Data Protection
    Policies & Procedures
    Privacy Law
    Data Privacy
    GDPR
  • $145 hourly
    My name is Stephen Prince and I am a USA Trademark Attorney who serves clients in all US states, territories, and countries around the world. I'm the attorney for more than 540 trademarks at the USPTO. I am an entrepreneur myself and understand that you want to protect yourself while working on growing your business. I know that the trademark process can seem complicated. Don’t worry, my aim is to clearly explain everything in easy to understand language so that you are comfortable with the process. Leave the complex legal issues to me as you are working on other aspects of your business. Feel free to ask me anything. I can help you as you navigate getting your trademark through the United States Patent and Trademark Office (USPTO). I can: - Register your brand name, logos, and slogans - Perform Trademark searches and give valuable feedback on whether your particular mark will make it through the USPTO process - Respond to USPTO office actions (both procedural and substantive) - Overturn 2(d) likelihood of refusal office actions - File Statement of Use forms - File extensions - Renew Trademarks - Assist with Amazon Brand Registry - Take care of Assignments (changing Trademark ownership from one company to another) - File US trademarks internationally through the Madrid Protocol. - Send or respond to Cease and Desist Letters - File oppositions/cancellations of trademarks - Send a Letter of Protest to the trademark office - Consult on any part of the Trademark process. Just ask. Let’s get your trademark completed correctly the first time so you don’t have to be delayed from protecting your brand. Let’s get your trademark started! I am licensed to practice law in Washington DC. I hold a Juris Doctor degree from the University of Miami School of Law and a Bachelor’s Degree from the University of North Carolina at Chapel Hill.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Trademark Prosecution
    Privacy Law
    Trademark
    Brand Licensing
    Limited Liability Company
    Trademark Registration
    Entity Framework
    Trademark Consulting
    Terms & Conditions
    Copyright
    Legal Entity Structuring
    Legal Research
    Trademark Search
    Legal
    District of Columbia Bar
    Contract Drafting
  • $125 hourly
    I specialize in developing Quality Management Systems for food and dietary supplement manufacturers. I also am highly experienced with supplement research and formulation, including CBD products. I am a regulatory liaison, therefore I am able to audit labels and websites to ensure they are FDA and/or USDA compliant. I am also experienced with OTC drugs such as hand sanitizer, topicals and alcohol wipes.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Research & Development
    Health & Fitness
    Food & Supplements
    SAP
    Compliance
    Nutrition
    Product Development
    Quality Control
    Microsoft Excel
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