We are seeking an experienced and highly motivated Regulatory Affairs Specialist with exceptional technical documentation skills to join our client's team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, assisting in the development of medical devices, and maintaining all relevant documents.
Key Responsibilities:
- Collaborate closely with cross-functional teams to ensure products meet necessary regulations
- Prepare reports on product safety evaluations
- Ensure that labelling complies with applicable laws/regulations
- Keep up-to-date knowledge about market authorisation processes both domestically (in Germany) and internationally
Qualifications & Skills Required:
- Regulatory Knowledge: The ideal candidate should have experience working with Class III Medical Devices (non-active)
- Technical Writing Ability: Strong writing ability is essential; you'll need excellent attention to detail when creating materials like instructions-for-use manuals or risk management plans. A background in scientific/medical communication would also be beneficial!
- German Language: Proficiency (C1)
- Remote Work Experience: As this position requires 100% remote work capability we require candidates who demonstrate strong self-motivation along effective project/time-management abilities
Apply to join a dynamic and highly flexible team. With an impressive compensation package, 100% remote working capability and a well structured progression scheme, this is a stand out opportunity. We look forward to receiving your application.
