OverviewThe Regulatory Affairs Specialist 2 helps develop regulatory strategies and performs activities associated with obtaining and maintaining regulatory approval to commercialize 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.
ResponsibilitiesMaintain 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.
Knowledge of relevant ISO, EU, and FDA medical device standards regulations is required.Ensure a thorough understanding of the products and/or regions they are assigned.Communicate country/region specific regulatory requirements.
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