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PROFESSIONAL SUMMARY With over two decades in the medical device sector, I am a seasoned Senior Medical Device Consultant offering comprehensive expertise in global marketing authorization, EU MDR compliance, and robust quality management systems. My specialization lies in ensuring medical device product compliance, spearheading both internal and external audits, implementing advanced risk management strategies, and guiding post-market procedures. My proficiency extends to the design and management of Unique Device Identifications (UDIs), and I possess a deep understanding of Software as a Medical Device (SaMD). Having hands-on experience with a spectrum of international regulatory frameworks, I am adept with guidelines from the FDA, EU MDR, MDSAP, MHRA, PMDA, JPAL, TGA, and ANVISA. My extensive knowledge also covers critical areas like distribution selection and liaison with local competent authorities. This ensures that the products not only meet global standards but also align with regional and local compliance requirements. In my consulting capacity, I've consistently been the trusted advisor to senior and executive management teams of my clientele. I provide strategic direction, clarity on compliance obligations, and navigate the ever-evolving landscape of medical device regulations. Furthermore, I offer companies' executive teams pointed direction on imperative action items and provide invaluable insights on managing relationships with distribution networks and local regulatory bodies. PROFESSIONAL SERIVCES 1. Global Marketing Authorization 2. Regulatory Compliance 3. Quality Management Systems (QMS) 4. Post-Market Surveillance (PMS) 5. UDIs Management 6. Clinical Evaluation 7. International Council for Harmonisation (ICH) 8. Medical Device Software (MDSW) & Software as a Medical Device (SaMD) 9. Data Protection Impact Assessment (DPIA) EDUCATION • BSI, AU - Management Systems Auditing, 2018 • BSI, ISO 13485:2016 Internal Auditor (TPECS), 2018 • BSI, MD - Medical Devices Quality Management Systems, 2018 • American Society for Quality, ASQ-Certified Six Sigma Green Belt, 2008 • Mohawk College, Mechanical Engineering, 2001-2004

Hi, I’m Shreya Zope — a Certified Food Safety & Regulatory Compliance Expert with 7+ years of experience helping exporters, importers, manufacturers, and warehouses in Canada and the U.S. stay compliant, audit-ready, and efficient. I combine my biotechnology background with graduate certificates in Food Safety & Quality (Conestoga College) and Supply Chain Management (Humber College) — along with advanced certifications including: ✅ SFCR (Canada) – Safe Food for Canadians Regulations ✅ PCQI – FSPCA – Preventive Controls Qualified Individual ✅ HACCP Level 4 Certified ✅ ISO 9001:2015 Internal Auditor ✅ BRCGS Internal Auditor My approach is practical, fast, and regulatory-accurate, designed to help food businesses achieve compliance with confidence. My Expertise Includes: 1) CFIA & FDA Food Label and Packaging Compliance Reviews 2) Custom SOP Templates for warehouses, manufacturers, and distributors 3) Import/Export Documentation Review for U.S. & Canadian markets 4) Food Safety Audits (HACCP, GMP, ISO 9001 readiness) 5) Internal Audits and QMS Implementation 6) Team Training on GMP, GLP, HACCP Standards I’ve helped CPG brands, breweries, logistics providers, and manufacturers: 1️⃣ Ensure products meet CFIA/FDA standards to avoid costly delays 2️⃣ Implement standardized quality systems and SOPs 3️⃣ Build preventive control plans and maintain audit readiness 4️⃣ Streamline supply chain operations while staying fully compliant Whether you’re preparing for certification, expanding into a new market, or simply want peace of mind with your documentation, I’ll help you simplify compliance and protect your business reputation. 📌 Let’s work together to make your food operations safe, compliant, and audit-ready — so you can focus on growth.

Regulatory environments don’t exist in isolation — neither should your compliance architecture. I help organizations navigate overlapping legal systems and AI-driven operational models through comparative regulatory analysis and structured risk mapping. The Comparative Advantage As a jurist with a Master’s in International & European Law, my expertise is defined by method, not by one statute. I analyze how regulatory frameworks intersect, where obligations converge or conflict, and how those tensions translate into operational exposure. My methodology converts legal complexity into structured risk matrices designed for: • Multi-Market Operations: Aligning compliance across jurisdictions while reducing redundancy and regulatory friction. • AI & Digital Innovation: Identifying exposure in AI-driven systems, data workflows, and copyright-sensitive environments. • Structural Risk Audits: Conducting large-scale gap analyses to detect systemic vulnerabilities before they escalate. Precision & Execution Strategic analysis must translate into operational clarity. I ensure compliance is reflected in every layer of documentation and implementation: • Cross-border contract review and DPA structuring • Policy drafting and decision-ready regulatory briefs • Technical legal proofreading in bilingual (English/French) regulatory environments • AI data integrity verification supporting legally sensitive workflows Selected Impact • Audited 200+ digital applications using a replicable comparative compliance framework • Delivered cross-border DPA harmonization and regulatory gap assessments • Designed end-to-end compliance modernization frameworks for digital communications and AI-enabled operations I don’t deliver abstract legal commentary — I provide structured regulatory roadmaps that decision-makers can act on with confidence.

ABOUT ME Regulatory documentation either moves your filing forward or it doesn't. I make sure it does. I'm a RAC-Drugs certified Regulatory Affairs consultant with 4+ years of hands-on experience supporting pharma, biotech, and medtech teams across FDA, EMA, Health Canada, CDSCO, and ICH frameworks. I deliver submission-ready documentation — not drafts that need rework. Most regulatory documents fail not because of bad science, but because they're poorly structured, inconsistently formatted, or not written to how reviewers actually think. That's the gap I close. What I Deliver: — IND/CTA and NDA/ANDA module drafting (Modules 2–5) — eCTD structure, publishing, and sequence preparation — Clinical writing: Protocols, IBs, CSRs, safety summaries — Labeling: USPI, SmPC, CCDS review and compliance — Regulatory gap analysis and audit readiness — SOPs, QA systems, CAPA documentation — Health Canada submissions and compliance strategy — MDR/IVDR: CERs, PERs, and technical file support Why Clients Choose Me: — RAC-Drugs certified — validated expertise, not self-declared — Top Rated Plus with 100% Job Success Score across all engagements — Structured, defensible documentation delivered on timeline — Direct, senior-level execution — no juniors, no handoffs — Built for lean teams and tight regulatory deadlines If your regulatory documentation needs to be submission-ready — not just technically complete — send me your project brief. I respond within hours and I don't deliver work that needs rework.

I help biotech startups, pharmaceutical companies, and research sites navigate the complexities of clinical trial operations, regulatory compliance, and site management. With experience in both the hospital research setting and the pharmaceutical industry, I specialize in regulatory documentation, IRB submissions, and end-to-end clinical trial execution. From study startup to closeout, I ensure compliance with FDA and ICH-GCP regulations, facilitate seamless collaboration between sponsors and sites, and optimize workflows to keep trials on track. As an independent consultant, I provide high-level regulatory and clinical trial support without the overhead of a full-time team, helping sponsors and sites streamline processes, maintain compliance, and successfully execute clinical trials from initiation to completion. SERVICES I OFFER REGULATORY & IRB SUBMISSIONS ✔️ Preparation and management of IRB submissions, protocol amendments, and informed consent forms ✔️ Regulatory document management and compliance oversight for clinical trials ✔️ Good Clinical Practice (GCP) compliance training and regulatory support for investigators and research teams CLINICAL TRIAL MANAGEMENT & OPERATIONS ✔️ Oversight of clinical trial activities from startup to closeout, ensuring compliance with regulatory requirements ✔️ Coordination of site regulatory documentation, essential document tracking, and audit readiness ✔️ Study feasibility assessments, site selection, and ongoing trial monitoring support FDA SUBMISSION SUPPORT & COMPLIANCE ✔️ Support for IND, IDE, and Pre-IND submission document preparation and review ✔️ Regulatory compliance consulting for FDA, ICH-GCP, and 21 CFR Part 11 requirements ✔️ Coordination of regulatory correspondence and submission strategy for clinical development programs DATA MANAGEMENT & MEDICAL WRITING ✔️ Case Report Form (CRF) development and electronic data capture (EDC) system support ✔️ Medical writing for clinical study documents, including protocols, investigator brochures, and study reports ✔️ Adverse event (AE/SAE) reporting support and regulatory compliance guidance 🔍 SKILLS & SERVICES Clinical Research, Clinical Trial Management, Regulatory Consultant, IRB Submission, FDA Submission Support, GCP Compliance, Site Regulatory Oversight, Clinical Trial Operations, Clinical Study Document Review, Investigator Training, Research Compliance, IND/IDE Submissions, 21 CFR Compliance, Medical Writing, Adverse Event Reporting, Study Feasibility, Site Selection, Audit Readiness Let’s connect! If you need expert support in clinical trial execution, regulatory compliance, or FDA submissions, I would love to hear from you.

Hello! I'm a regulatory compliance and quality systems consultant providing the following services: - CanadaGAP, GlobalGAP, BRCGS and SQF and Food Safety and Quality Management System building, compliance and audits. - Food Label review - human and animal foods. - Food Safety Plan/HACCP Plan Development - CAPA Program Development - Hazard Analysis and Risk Assessments - AAFCO compliance and ingredient definition requirements. - Compliant Nutritional Panel Development for Canada and USA (including bilingual French) (FDA and CFIA compliant labels) - General Food Safety/Food Quality related queries - FDA Domestic & Foreign Food Facility Registration - SOPs writing and policy development. - Non-GMO Project Verified (NGPV), Bioengineered Foods Compliance - Regulatory audits compliance such as FDA and CFIA and customer audit requirements such as Abbott, Nestle, Aldi, and Mondelez. - Building robust Listeria prevention programs. - Food defense program building and implementation. - FSVP compliance. - Preventive Control Plans (PCP) compliance and implementation. - Supplier Approval Program Development - Supplier Approval Audit Requirements. - Aseptic Processing Compliance - Better Process Control School - Offer training and coaching for teams in internal auditing, HACCP, GMPs. Standards & Certifications: CanadaGAP, SQF, BRCGS Food Safety Issue: 9, FSSC 22000, ISO 22000, PCQI, HACCP, Non-GMO Project verified, Organic - NOP, COR and EU, Kosher, Halal, cGMP, Internal Auditing, SFCR Registration, FDA Registration, FSMA Compliance, Food Defense Plan, Listeria Control and Prevention, AAFCO compliance, PCQI - Human Foods, PCQI - Animal Foods, Aseptic Processing, Better Process Control School Certified Whether you are a small or medium-sized business owner or employee looking for some help or brainstorming ideas for implementation, you're at the right profile! Feel free to hit me up with your questions and I'll be more than happy to be of service! #CanadaGAP #SQF #BRCGSFoodSafetyIssue9 #FSSC22000 #ISO22000 #PCQI #HACCP #NonGMOProjectVerified #OrganicNOP #OrganicCOR #OrganicEU #Kosher #Halal #cGMP #InternalAuditing #SFCRRegistration #FDARegistration #FSMACompliance #FoodDefensePlan #ListeriaControlAndPrevention #AAFCOCompliance #PCQIHumanFoods #PCQIAnimalFoods #AsepticProcessing #BetterProcessControlSchoolCertified #PetFoods #BeverageProcessing #BabyFoods #Baking