Regulatory Affairs Specialist IV
Company Summary:
My client is a global leader in creating high quality and affordable In-Vitro Diagnostics and medical devices to over 130 countries around the world. They are looking to add a Regulatory Affairs Specialist IV to their team in San Diego, CA!
The Regulatory Affairs Specialist IV will be responsible for:
- Drafting, editing and compiling technical documentation and design dossier in support of CE Mark/UKCA mark regulatory filings.
- Coordinating submission/review of documents for Design History Files.
- Preparation of post-market product surveillance reports, EU/UK vigilance reports, and regulatory submissions for FDA A2F.
- Keep up to date with FDA, CMDR, MDR, IVDR, and UK MDR2002 guidance documents for regulatory requirements.
The Regulatory Affairs Specialist IV should have the following qualifications:
- Bachelor's degree and 6+ years IVD industry experience
- 3+ years experience preparing and submitting 510k or CE technical files for IVDs
