Regulatory Affairs Specialist 2 Overview
The Regulatory Affairs Specialist 2 develops regulatory strategies and performs activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in targeted markets. This role serves as a communication liaison between the Cook manufacturer and local affiliates, distribution partners, or regulatory authorities.
This position reports to the Team Lead, Regulatory Affairs or Manager, Regulatory Affairs.
Main Responsibilities
* Maintain comprehensive knowledge of global medical device regulations for assigned jurisdictions, including ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21CFR Part 820. In-depth understanding of relevant ISO, EU, and FDA medical device standards is essential.
* Ensure a thorough understanding of assigned products and/or regions.
* Communicate country-specific regulatory requirements effectively.