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
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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.
- Ensures a thorough understanding of the products and/or regions they are assigned.
- Communicates country/region specific regulatory requirements