CK Group are recruiting for a Regulatory Affairs Director to join an innovative invitro diagnostics company who are breaking into the US market. This is a remote vacancy open to both permanent hires and consultancy agreements.
Regulatory Affairs Director Role:
The Regulatory Affairs Director will be responsible for the regulatory activities involving IVD medical devices (assays, instruments and ancillary reagents) across the company with a focus on the North American markets.
Further duties include to:
? Serve as primary communicator with FDA for both oral and written communications and reporting, ensuring reports are compiled, approved, and distributed to appropriate internal personnel as well as external agencies. Also manage the preparation and quality check of all regulatory submissions to regulatory agencies primarily FDA.
? Executes appropriately on MDR reporting and product recalls. Respond to regulatory agency inquiries.
? Author pre-market submissions, including 510(k)s and PMA supplements to the U.S. FDA and Health Canada in alignment with pre-market strategies,
? Assist with managing Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market.
? Degree in science relating to microbiology or biomedical science is desirable
? 510(k) experience required, EUA, IDE, PMA
? Proficient in Quality Systems Regulation (21 CFR part 820) and ISO 13485
? Proven experience of direct interaction with FDA reviewers/inspectors
? RAPS certified ? RAC Devices
? Working knowledge of 21 CFR part 803, and other chapters relating to IVDs
Entitlement to work in the USA is essential. Please quote reference 51556.
You MUST be eligible to work in United States. Learn more
- Agency: CK Group
- Contact: Alex Tosney
- Phone: 01246 457718
- Reference: 51556
Website: CK Group
- Posted: 3rd September 2021
- Expires: 1st October 2021