What will your main tasks be?
- Prepare and update clinical evaluation plans and reports (CERs) for Class III medical devices;
- Liaise with internal and external stakeholders to ensure timely completion of CERs;
- Prepare and update PMS plans, periodic safety update reports (PSURs), post-market clinical follow-up (PMCF) plans and reports, and summaries of safety and clinical performance (SSCPs) for Class III medical devices;
- Conduct clinical literature and vigilance database searches;
- Conduct PMCF studies (e.g.surveys) and collaborate with the Product Management Department or support consultants conducting such studies;
- Implement scientifically and statistically sound methods into study plans and data analyses;
- Participate in the design, management and reporting of clinical investigations as required;
- Liaise with Sales, Marketing and QA Departments to ensure PMS activities are conducted under regulatory supervision;
- Ensure relevant CE marking documents, including product technical files, are complete and up to date;
- Perform vigilance activities as required.
You will also have to ensure that the organisation consistently meets legal obligations, focusing on:
- Compliance with the Medical Device Regulation (MDR) for Class III medical devices;
- Clinical evaluation requirements under the MDR;
- Post-market surveillance (PMS) requirements under the MDR.
Bedrijfsprofiel:
Join a leading innovator in the dental industry as a Clinical Regulatory Affairs Specialist.Do you want to advance your career with a globally recognized company known for its high-quality products, and already have some experience in clinical research and medical writing?Then this role is perfect for you!
