As part of your role as a Product Reviewer, you will be responsible for reviewing technical documentation from various manufacturers either independently or as part of a multidisciplinary team supporting various certification projects, with the aim of verifying that the devices meet the requirements of Regulation (EU) 2017/745. Ultimately, your work will determine whether a device can be demonstrated to be safe and effective and can be recommended to the Notified Body for CE certification. Essential Functions: โ Conduct and evaluate CE product assessments against the requirements of the MDR for a wide range and class of medical devices, depending on your area of expertise โ Coordinate with other product reviewers, clinical specialists, and the project managers to meet the review timelines, and deliver high-quality reports โ Ensure active regulatory monitoring and reporting to the team for any new publications/requirements identified in your specific area of device expertise โ Perform other duties and responsibilities as required or requested Required Education and Experience: โช Successful completion of a university/technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering disciplines or other relevant scientific study. โช 4 years of professional work experience in medical device manufacture, R&D, healthcare products or related activities, of which 2 years should be in the design, manufacture, testing, or use of the device/technology to be assessed (active/non-active devices, aligned to MDA/MDN codes) โช Sound knowledge of Regulation (EU) 2017/745 (MDR) as well as related harmonised/state-of-the-art standards, Common Specifications and MDCG guidance documents โช Knowledge and experience in risk management (ISO 14971) โช Work Experience in a Notified Body is of advantage
