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Job Overview
This Regulatory Affairs Specialist 2 role is responsible for ensuring EU MDR compliance at the EU Authorised Representative office. The successful candidate will act as a liaison between Cook Medical's non-EU manufacturers and the EU regulatory authorities.
Key Accountabilities- Cultivate and maintain an exceptional understanding of EU medical device regulations (EMEA, UK, Switzerland, EN ISO13485).
- Foster strong relationships with Cook manufacturers to ensure thorough knowledge of assigned products.
- Work collaboratively with global project managers, EU MDR, and other team members to successfully implement EU MDR requirements at the EU AR office and sister Cook companies.
- Develop and maintain processes/procedures within the QMS to effectively carry out EU AR duties as outlined in Article 11 of EU MDR.
- Nurture close working relationships with relevant Cook manufacturing sites to ensure contracts/Mandates are in place between the EU AR and represented manufacturers.
- Serve as a primary point of contact for Competent Authorities regarding information requests, documentation/samples, reportable incidents, and field safety corrective actions.
- Deliver EU AR duties under Article 11 and 12 of EU MDR, MDD agreements, and conduct post-market surveillance monitoring as necessary.
- Stay abreast of legislative and regulatory developments, updating processes/procedures as required, and reporting potential impacts on the company to local/global leadership.
- Effectively coordinate multiple projects simultaneously, providing regular reports to regulatory management and others as needed.
