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 6-7 years IVD industry experience with a minimum 3 years’ experience in preparation and submission of 510k or CE technical files for IVD devices.
Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.

Senior Regulatory Affairs Specialist (IVD, Hybrid)