One of the world's leaders in medical device manufacturing, is looking for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for guiding the production, marketing, and distribution of Class I and II electromechanical devices and disposables to verify that all functions are in compliance. Core Responsibilities * Compile and maintain 510(k), Technical File and other regulatory files, in a format consistent with requirements. Complete memos to file assessing changes. * Project Management for compliance projects * Complete product and facility registrations, license extensions and amendments, renewals according to agreed timeline, ensure approvals in a timely manner * Unique Device Identifier (UDI) implementation and maintenance Core Requirements * 6-10 years of regulatory experience in medical device industry with products marketed in the US, Canada, and EU. * Minimum of a Bachelor's Degree * Proficient in 21 CFR 820 and the Medical Device Directive and Canadian Medical Device Regulations Apply now by forwarding your resume and/ or reaching out to me on the details below.
Sthree US is acting as an Employment Agency in relation to this vacancy.