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Compliance Officer for Medical Devices
1 week ago
Cook Medical is a leading manufacturer of medical devices, and we are seeking a highly skilled Compliance Officer for Medical Devices to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our products meet the highest standards of quality and safety.
Key Responsibilities- Assist in the implementation of regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA 21CFR Part 820 as required.
- Develop and maintain a system for registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations.
- Stay up-to-date on global medical device regulations and communicate any changes or updates to relevant stakeholders.
- Provide regulatory support to Cook Medical functional units such as SSC, tenders, customer quality, and distribution.
The ideal candidate will have a third-level qualification in science, engineering, or a related field, and at least two years' experience in a regulated industry in a similar role. A good understanding of relevant ISO, EU, and FDA medical device standards and regulations is also essential.
