Regulatory Affairs Specialist for Medical Devices & IVD  

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:

• 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.
• 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.
• Strong working knowledge of iso 13485, iso 14971, and at least one major regulatory market (European mdr 2017/745, ukca, or United States fda 510(k)/Part 820). Multi-market experience across these regions is highly advantageous.
• 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.
• 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.