Author Submissions & Technical Files: Draft and compile technical documentation for EU MDR (Annex II/III), UKCA, and FDA 510(k) submissions
Maintain QMS Compliance: Support and manage ISO 13485-compliant Quality Management Systems
Conduct Gap Analyses: Perform regulatory gap assessments against relevant regulations
Manage Risk & Clinical Data: Prepare risk documentation and draft/review Clinical and Performance Evaluation Reports
Drive Post-Market Activities: Support PMS activities and vigilance monitoring
Handle Agency Queries: Draft responses to regulatory inquiries
Ensure Audit Readiness: Maintain organized regulatory files and submission trackers
Monitor Intelligence: Track evolving regulatory requirements

At least 2 years of hands-on QA/RA experience strictly within the medical device or IVD industry
A background in biomedical engineering, life sciences, or a related technical discipline is highly valued
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)
Experience independently leading full submissions end-to-end or successfully resolving Notified Body/regulator queries is a major plus
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
Self-starter who thrives in a remote environment

Regulatory Affairs Specialist – Medical Devices, IVD

Key skills