About the role:
As a Regulatory Affairs Specialist within the EMEA PMS CoE, you will support the execution of post-market surveillance activities across the region. You will contribute to the implementation of a harmonized and efficient PMS operating model, ensuring compliance with EU MDR and other applicable regulations. This role is critical to strengthening the CoE’s capacity and enabling the transition of responsibilities from local RA teams to the centralized structure.
Your responsibilities will include:
1. Support the preparation of PMS documents, such as FSCA reports, FSN /customer letters and responses to competent authorities questions.
2. Support in addressing vigilance additional information requests originating from Competent Authorities within the Central/Western cluster.
3. Coordinate with local RA teams, QA, and Field Action teams to gather post-market data.
4. Assist in the development and maintenance of templates and tracking systems and KPIs.
5. Ensure timely and accurate submissions to Competent Authorities in line with regulatory requirements.
6. Contribute to continuous improvement initiatives within the CoE, including process optimization and knowledge sharing.
7. Maintain up-to-date knowledge of applicable regulations.
8. Contribute to regulatory intelligence on PMS related topics.
What are we looking for in you?
9. Bachelor’s degree in Life Sciences, Engineering, or related field.
10. 2+ years of experience in Regulatory Affairs, preferably with exposure to post-market activities.
11. Familiarity with EU MDR, vigilance reporting, and FSCA processes.
12. Strong organizational and communication skills.
13. Ability to work in a matrixed, multicultural environment.
14. Fluent in English; additional EMEA languages are a plus.
Interested? Please apply online with your CV in English
Requisition ID: 613974
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