Regulatory Affairs Specialist

Shift: Monday through Friday 8am - 5pm Length: 12-24 month contract with a possibility of extension or conversion to full-time Hybrid schedule: 2-3 days onsite 3 must haves: BA/BS/MS degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline Must have 2+ years of professional experience in Regulatory Affairs (IVD) Must be able to pass a background and drug screen.

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 • Maintain library/database of technical documentation • Monitor the status of standards and regulations.

Conduct a review and analysis in case if requested.

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.