Regulatory Affairs IVD Lead (Senior Manager/Associate Director Level)
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 lead to their team - this position is comparable to a Senior Manager/Associate Director level position! This role will be hybrid and located in St. Louis Missouri!
The Regulatory Affairs IVD Lead 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 Lead should have the following qualifications:
- 3+ years of Regulatory Affairs IVD experience
- 2+ years of management experience
- Expertise in IVD combined with knowledge of the market, competitors, and authority landscape.