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High Salary Regulatory Affairs Specialist 2

4 weeks ago

Limerick, Limerick, Ireland Cook Medical Incorporated Full time
Overview

The 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.

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. 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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