We are hiring a Senior Regulatory Specialist for an established in-vitro diagnostics company in San Diego, CA. This is hybrid on-site role 3 days per week and requires at least 5-7+ years of hands-on Regulatory experience including 510(k) authorship.
Responsibilities
- Coordinates submission and review of documents for Design History files.
- Drafts, edits and compiles technical documentation and design dossier in support of CE mark regulatory filings.
- Responsible for the preparation of post-market product surveillance reports
- Responsible for the preparation of EU vigilance reports as needed.Prepare regulatory submissions for FDA A2F.
- Assist on the Registration/Application of Class II & III Medical Devices Licenses in Health Canada.
- Research FDA, CMDR, MDR, IVDR and UK MDR2002 guidance documents for regulatory requirements.
- Review labeling, package inserts, ad materials and company website to meet FDA and CE regulatory requirements.
- Maintain, track and/or update regulatory documentation.
- Maintain Essential Requirements Checklists- ensuring that applicable standards are utilized and updated as revisions are introduced.
- Provide Technical Documentation to Competent Authorities and Notified Bodies.
- Assist OEM customer in obtaining the CE mark on their products.
Background Requirements:
- Bachelors in related discipline or equivalency;
- Minimum 5-7 years IVD industry experience with a minimum 3 years’ experience in preparation and submission of 510(k)'s and CE technical files for IVD devices.
- Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.
