Description:
Manages the regulatory strategy for products governed by EU legislation and standards.

Key Responsibilities:

1. Develop regulatory strategies for EU markets

2. Prepare and manage Technical Files

3. Communicate with Notified Bodies

4. Ensure ongoing compliance with MDR/IVDR/CE

5. Support market authorisations and renewals

General Requirements:

• Degree in Life Sciences, Engineering, or Regulatory Affairs

• Strong knowledge of EU MDR, IVDR, CE marking

• Experience with regulatory submissions

• Strong communication skills

• 8–10 years of experience

Location: Europe

For more information, please contact: Nedera
Nedera will make tailor-made actions to ensure the best suitable selection process.