Regulatory Affairs Specialist IVD
Company Summary:
My client, a global leader in the medical device, pharma, and biotech industry has built out one of the most diverse portfolios with some of the most successful products in the industry! They are looking to add a Regulatory IVD Specialist to their team! This position will by hybrid and located in St. Louis Missouri, they can help out with relocation if required!
The Regulatory Affairs IVD Specialist will be responsible for:
- Managing assigned regulatory tasks related to health authority notifications, submissions, and registrations and ensuring the site regulatory strategy aligns with overall corporate regulatory strategy and goals.
- Assembling and maintaining technical files and other regulatory documents to ensure timely registrations and renewals.
- Advising in activities related to regulatory registrations with focus on In Vitro Diagnostic regulations (IVDR, compliance with FDA 21 CFR 820, and other international medical device registrations)
The Regulatory Affairs IVD Specialist should have the following qualifications:
- Master's or Bachelor degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science field with 1+ years' experience in medical device regulatory affairs
- Expertise in Medical Devices combined with knowledge of the market, competitors, and authority landscape.
- IVD expertise would be a plus but not required.
- Able to work both in a team situation and individually with minimal supervision.
