Overview
The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates, distribution partners or regulatory authorities. Reporting to: Team Lead, Regulatory Affairs or Manager, Regulatory Affairs Find out more about Cook Medical here
Responsibilities
Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required. Knowledge of relevant ISO, Eu, FDA medical device standards regulations is required. Ensures a thorough understanding of the products and/or regions they are assigned. Communicates country/region specific regulatory requirements