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You will be working in a team that develops clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations (MDCG 2020-6). Your work will support CE Mark applications, recertifications, and proposed indication/labeling changes, ensuring EU product conformance. You will also develop and review Post Market Clinical Follow-up (PMCF) strategies, participate in Risk Management assessments, and Post Market Surveillance (PMS).
What you’ll do:
Clinical Evaluation (35%)
1. Develop and prepare Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
2. Conduct systematic literature research to support clinical evaluations and regulatory submissions
Post Market clinical follow up activities (30%)
3. Assist in the development and execution of PMCF plans and reports
4. Collect, analyze, trend, and report on safety data
Clinical Studies activities (25%)
5. Organize and execute pre and post-market clinical trials
Collaboration (10%)
6. Collaborate with product managers, regulatory affairs managers, and other team members
What you’ll need:
7. Experience in developing Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
8. Strong skills in conducting systematic literature research
9. Ability to develop and execute PMCF plans and reports
10. Proficiency in safety data analysis and reporting
11. Experience in organizing and executing clinical trials
12. Excellent collaboration skills with cross-functional teams
Why you should apply:
Join us to be part of a dynamic team that is at the forefront of clinical affairs. You will have the opportunity to work on innovative projects to create the next generation of our devices, ensuring compliance with changing regulations and contributing to continuous improvement activities. This role offers a chance to make a significant impact on product development and market clearance processes.
You will be working in the EMEA HQ of a market leader amongst 30+ different nationalities.
Home working possibilities for 2 days a week