Regulatory Affairs Specialist (Medical Devices & IVD)

About Expedock We are a tech-enabled workforce augmentation platform leveraging top 1% offshore talent & cutting edge technology to enable businesses to unlock their full potential. About the Client An established international regulatory affairs and QA consultancy specializing in the medical device and IVD sectors. They provide global compliance, technical documentation, and QMS solutions to a diverse client base ranging from early-stage startups to major multinational corporations. Schedule: Mid Shift Location: Fully Remote (WFH) Who We Need Our client is looking for an experienced, remote Regulatory Affairs Specialist with a strong track record in medical device or IVD documentation. In this role, you will partner directly with their international clients to guide them through EU MDR, UKCA, and US FDA frameworks. They need a self-starter who can work independently across time zones, write flawless English, and take a highly practical, hands-on approach to compiling submissions and managing quality systems. What You'll Do: Author Submissions & Technical Files: Draft and compile technical documentation for EU MDR (Annex II/III), UKCA, and FDA 510(k) submissions, including GSPR checklists, risk management files, and device descriptions. Maintain QMS Compliance: Support and manage ISO 13485-compliant Quality Management Systems, including SOPs, work instructions, change control processes, and audit preparation. Conduct Gap Analyses: Perform regulatory gap assessments against EU MDR 2017/745, EU IVDR 2017/746, UK MDR 2002, and FDA 21 CFR Part 820. Manage Risk & Clinical Data: Prepare risk documentation (ISO 14971) and draft/review Clinical and Performance Evaluation Reports (CERs/PERs). Drive Post-Market Activities: Support PMS activities, including PMCF planning, PSUR/PMS reporting, and vigilance monitoring. Handle Agency Queries: Draft responses to Notified Body queries, MHRA requests, and FDA information requests for client submissions. Ensure Audit Readiness: Maintain organized, version-controlled regulatory files and submission trackers to ensure all documentation is audit-ready. Monitor Intelligence: Track evolving regulatory requirements across the US, UK, and EU, and communicate impacts to the broader team. What You Need: You have at least 2 years of hands-on QA/RA experience strictly within the medical device or IVD industry (pharmaceutical-only backgrounds will not be considered). A background in biomedical engineering, life sciences, or a related technical discipline is highly valued. You have a track record of personally writing and compiling technical documentation—not just reviewing it . Experience independently leading full submissions end-to-end or successfully resolving Notified Body/regulator queries is a major plus. You bring a strong working knowledge of ISO 13485, ISO 14971, and at least one major regulatory market (EU MDR 2017/745, UKCA, or US FDA 510(k)/Part 820). Multi-market experience across these regions is highly advantageous. You ideally have exposure to specialized standards like IEC 62304 (software), IVD requirements, or EUDAMED, alongside familiarity with eQMS platforms (e.g., Qualio, Greenlight Guru, MasterControl). RAPS RAC certification is a plus. You possess flawless written English tailored for regulator-facing documents . You are a self-starter who thrives in a remote environment, managing deadlines and collaborating seamlessly across international time zones with minimal supervision. Candidate Data & Privacy Notice By submitting your application to Expedock, you acknowledge and consent to the collection, use, and processing of your personal information for recruitment and hiring purposes. Your information will be used to: Evaluate your qualifications and suitability for current and future roles Communicate with you throughout the recruitment process Improve our hiring processes and overall candidate experience Maintain talent pools for future opportunities, where permitted by law We handle candidate data with care and in accordance with applicable data protection and privacy regulations. Your information will only be accessed by authorized team members and will not be shared with third parties without your consent, unless required by law.