- Our company is the global leader and innovator in inspection, verification, testing and certification services.
- Founded in 1878,our company is recognized as the global benchmark in quality and integrity.
- Trusted all over the world, our company is a market leader because we put 100% passion, pride and innovation into everything we do.
- We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.
Medical Device Contract Reviewer
- To review medical devices questionnaires and prepare proposals and worksheets promptly to avoid customer delays
- To approve worksheet documents in a timely manner to maximize revenue generation
- To review client vigilance reports, monitor trends in client reporting, and to ensure appropriate action is taken by our company in a timely fashion
- To ensure company affiliates are made aware of vigilance issues for their clients, and that audits are planned accordingly to address vigilance concerns
- To operate as a technical resource within the medical device team and ensure that technical queries are adequately answered or forwarded to the appropriate technical expert of manager
- Answer queries from company affiliates and clients in a timely manner, ensuring a prompt and efficient service
- To review and approve the Technical file Matrices to ensure technical file sampling is undertaken to regulatory requirements
- To undertake other technical tasks as requested and support company affiliates on technical projects
- The successful candidate will hold a technical qualification ideally relevant to medical device (e.g. electronics, nursing, biology, pharmacy, materials) and will have significant technical experience, either via medical device clinical use or design / manufacture
- The role will involve extensive use of databases and spreadsheets, strong administrative and computer literacy and experience of databases and spreadsheets is therefore essential
- The ideal candidate must demonstrate excellent attention to detail and effective communication skills, and also have the ability to effectively manage and organize day to day priorities
- Internal audit training or knowledge of the medical devices directive and ISO 13485 would be advantageous, however this role would suit an enthusiastic and bright individual with the ability to learn quickly and develop a strong understanding of new technical issues relating to medical devices
- University Degree or equivalent