Hire the best Regulatory Compliance Freelancers in San Diego, CA

Check out Regulatory Compliance Freelancers in San Diego, CA with the skills you need for your next job.
  • $140 hourly
    Professional Summary Highly experienced attorney providing in-house legal services with a strong background in healthcare, business transactions, ensuring corporate compliance, advising on legal and regulatory requirements, employment law, conducting organizational investigations and audits, supervising outside legal counsel, policy analysis, providing internal training and board/executive presentations, managing and mentoring colleagues, and advising on antitrust matters. Specialties: healthcare * telehealth * Med Spas * contract drafting * contract negotiation * contract interpretation * compliance * HIPAA * employment * corporate practice of medicine * stark * anti-kickback * False Claims Act *Affordable Care Act * Knox-Keene * antitrust * non-profit * policy analysis * training * group purchasing organizations * managed care/payor contracting * utilization management *physician contracting * corporate governance * pharmacy * behavioral health * IT contracting *
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Legal Negotiation
    Telemedicine
    HIPAA
    Policy Development
    Policy Analysis
    Law
    Healthcare
    Corporate Law
    Privacy Law
    Contract Drafting
    Employment Law
  • $70 hourly
    I am new to Upwork so you won’t see a lot of work history here, but I am happy to provide references. I bring a nerdy fascination with regulatory guidelines and corporate culture, a holistic approach to problem-solving, and a knack for diplomacy and negotiation to every project I tackle. I have worked in North America, Europe, and Africa; have supported teams in local, state, country, and global initiatives; and worked within public, private, non-profit, and start-up organizations. Having held positions in strategic communications, program development, client relations, and operational strategy, I bring a well-rounded skillset to the table. My interests include program development, research and data analysis, and strategic planning, and I enjoy the challenges associated with change and aligning cross-functional teams. Most of my work experience has involved energy management, utilities, and regulatory compliance, and more recently I’ve dipped into helping real estate owners navigate complex building codes. I can take on everything from interviewing stakeholders, writing proposals, and presenting solutions, to executing strategic plans and leading teams for measurable results. Though my background speaks to a penchant for making seemingly boring things interesting, I am an artist, philosopher, and humanist who cares deeply about productive communication and genuine dialogue. I excel in breaking through roadblocks and look forward to working with your team to the world a safer, more sustainable place for us all!
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    Project Management
    Energy & Utilities
    Energy Management
    Compliance Consultation
    Operational Planning
    Data Analysis
    Research & Strategy
    Proposal Writing
    Program Curriculum
    Communications
    Program Management
    Environmental, Social & Corporate Governance
    Cross Functional Team Leadership
    Strategic Planning
  • $60 hourly
    REGULATORY AFFAIRS EXECUTIVE AND LEADER, 16+ years of experience who navigates innovative environments and safeguards regulatory alignment of Class I, II, and III medical devices within FDA & EU/OUS landscapes. Device experience includes Digital Drug Infusion Pumps, Medication management systems, Spine Robotic AI driven Med. devices, Spine Surgical Intelligence & Global Sterilized Implants, Remote Patient Monitoring Software system, Genome/Genetic Diagnoses Sequencing, digital health applications, and medical device software. Builder of robust regulatory visions and strategies, breaking down barriers to obtain timely regulatory clearance, support pipeline development, and accelerate time to market. Hands-on experience authoring submissions including FDA 510(k)s, PMAs, IDEs, STED files, CE Mark notified bodies. Thrives in fast-paced environments with defined cross-functional partnerships and strong team cultures in place. Showcased alignment to advancing regulatory landscapes, and impressive history supporting game-changing products and diverse therapeutic areas. Quick to uncover root causes and drive focused resolutions to ensure sound processes, deep regulatory knowledge, and clinical/scientific operations.  Defined end-to-end regulatory experience and strategy within growing Spine Surgery Robotic division for innovative products involving Artificial Intelligence (AI). Various Digital Health Software applications.  Applauded with Nuvasive’s Global Regulatory Excellence Award nomination.  Comprehensive understanding and application, EU regulations, laws, guidance, and standards, e.g., 21 CFR 820, MDD, MDR, ISO13485:2016, ISO14971:2019, ISO 14155, ISO 10993 Bio Compatibility, Cybersecurity, Usability, IEC 60601-1 series, ISO 62304, IEC 62366, ROHS, REACH, RED etc. Leadership & Team Building | Regulatory Affairs | Medical Device Design | Strategic Planning & Execution Competitive Intelligence | Regulations & Standards Expert | AI ML Algorithms | FDA & EU Regulations | FDA Submissions EU MDR Transition | 60601-1 Series | Risk Management | Human Factors | Quality System Regulations IEC82304 Health Software | IEC62304 | Usability | IEC 10993-1 Series| Clinical| Labelling Strategy DIRECTOR REGULATORY & QUALITY AFFAIRS (RA/QA) – ARTIFICIAL INTELLIGENCE(AI) & CYBERSECURITY Managed Regulatory submissions for product approvals and licensing in United States & EU Guided next-generation digital health technologies and evaluated progress against metrics that spanned cost, timeline, technical specifications, and quality. on IDEs and clinical trials. Recruited to author and oversee FDA 180-day PMA-S, IDE-S, post-approval study protocols, and EU tech files. Reviewed labeling and promotional materials ▪ Authored, reviewed, and managed files for regulatory submissions including technical files for CE mark, EU MDR Transition FDA, as well as pre-submissions for 510(k) and de novo applications. ▪ Regulatory representative on multiple boards, Auditing Head for business units and steering committees, and built regulatory strategies, Managed & led Notified Body BSI, FDA, MDSAP and country-specific audits. ▪ Responsible for companywide regulatory compliance, including labeling and promotional materials. ▪ Mentored teams on Artificial Intelligence Machine Learning Algorithm and Cyber security deliverables and integrating them in the Quality Design Controls of the QMS. DIRECTOR REGULATORY & QUALITY AFFAIRS (RA/QA) – ARTIFICIAL INTELLIGENCE(AI) & CYBERSECURITY CLASS II & III MED DEVICE SUBMISSIONS | FDA EU REGULATIONS | SAMD/SIMD|DIGITAL HEALTH | ARITIFICIAL INTELLIGENCE (AI & ML) | CYBER SECURITY CAREER HIGHLIGHTS CORE STRENGTHS & COMPETENCIES PROFESSIONAL EXPERIENCE NUVASIVE – San Diego, CA | Jan 2021 – Jan 2024 Lead a team of 10 inside new device and digital health vertical – software function – breaking down barriers to advance initiatives and product lines. Direct regulatory affairs for Surgical spinal navigation system, Robotic surgeries through artificial intelligence, radiation reduction and image processing system, intraoperative neuro monitoring system, and computer-assisted spinal fixation rod bending system and digital health solutions. Own global regulatory assessment of digital health solutions for conformation to SaMD/MDSW regulations. Interact with global government regulatory agencies, auditors, and notified bodies. ▪ Spearheaded build of the complete regulatory experience and global regulatory strategies within the Surgical Intelligence division for products involving AI and machine learning. Instituted biweekly deep dives into FDA guidelines to ensure high-level knowledge transfer and more proactive strategy/project planning.
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    Design & Usability Research
    Quality Assurance
    Regulatory Intelligence
    Medical Device
  • $17 hourly
    Healthcare professional with over four years of experience in providing medical writing services to some of the world's largest pharmaceutical companies. Twice received certificates of appreciation from Johnson & Johnson for conducting an accurate case analysis of Remicade Human Papilloma Virus (HPV), Dysplasia and Cervical Cancer, and for reviewing and annotating 700+ cases of adverse drug reactions to esketamine. Furthermore, I was recognized in the Empowerment and Accountability category and several other categories in the Parexel Country Manager's Recognition program for outstanding performance. Analyzing patient health records and using data-driven insights in healthcare decision-making motivated me to specialize in healthcare analytics and explore digitally enabled care. This experience broadened my perspective, extending from dental practice to drug discovery and big pharma.
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    Scientific Literature Review
    Research Proposals
    Project Workflows
    Data Analysis
    Gantt Chart
    Electronic Health Record
    Medical Terminology
    Data Visualization
    Healthcare Interoperability
    Healthcare IT
    Medical Writing
    Clinical Trial
    Analytical Presentation
    Pharmacovigilance
  • $250 hourly
    I'm a seasoned business consultant with over 25 years of experience guiding companies from ideation to successful exits. My expertise lies in three key areas: Global Sourcing: I've established strong partnerships and deep knowledge of product sourcing in Asia, including China, South Korea, Taiwan, and Japan. Need help finding the perfect supplier or navigating import/export logistics? I'm your guy. Operational Efficiency: From startups to established businesses, I can help you streamline operations, maximize efficiency, and achieve sustainable growth. My experience managing companies of various sizes gives me a unique perspective on building scalable and robust systems. M&A Expertise: Thinking about selling your business? I've successfully led and sold two diagnostics companies to Fortune 500 corporations. I can help you prepare for a smooth and profitable exit, from valuation strategies to deal negotiation. Whether you're a startup founder looking to source products, a growing business seeking operational improvements, or an entrepreneur aiming for an ideal exit, I can be your strategic partner. Together, we'll turn your vision into a thriving reality.
    vsuc_fltilesrefresh_TrophyIcon Regulatory Compliance
    Product Development
    Product Sourcing
    Mergers & Acquisitions
    Import Procedure
    Supply Chain Management
    Supplier Search
    Business Consulting
    Startup Consulting
    Business Development
  • $45 hourly
    Currently a Quality Engineering Manager with a wide range of engineering skills and services which include but are not limited to: Technical document generation & review, SolidWorks & 2D product drawing development, Microsoft Excel creation, data analysis and visualization and much more! I have experience in quality engineering, process engineering, manufacturing engineering, mechanical engineering, supplier quality engineering, project & people management. Motivated and people orientated engineer with a degree in mechanical engineering from the University of Wisconsin - Madison. Lean Six Sigma Black Belt and MDSAP internal auditing certified.
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    Supplier Development
    Problem Solving
    Data Analysis
    Quality Inspection
    Microsoft Office
    SolidWorks
    Quality Control
    Quality Management System
    2D Product Drawing
    Technical Documentation
    Review
    Microsoft Excel
    Technical Project Management
    Technical Documentation Management
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