Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Location: 63103, St Louis, Missouri, United States

Duration: 24 Months

Job Description:

With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale of products ensuring continual compliance to all applicable regulations and ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives.

Independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals.

Assist and advise in activities related to regulatory registrations, listing, and regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations

Education & Experience:

Bachelor's or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline

2+ years of professional experience in Regulatory Affairs (IVD)