Regulatory Affairs Specialist
Regulatory Affairs Specialist
Location: Berlin (on‑site 1-2 days per week)
Sector: Medical Devices | Life Sciences
Overview
An innovative life‑science company based in Berlin is seeking a Regulatory Affairs Specialist to support the next phase of regulatory development for a unique biochemical medical device.
This is an excellent opportunity for a Regulatory Affairs professional to take ownership of critical regulatory activities.
Key Responsibilities
- Prepare, compile, and maintain technical documentation for regulatory submissions
- Support the transition from MDD to MDR, including gap assessments
- Contribute to the preparation of MDR technical files and submission materials
- Ensure compliance with applicable EU regulations and standards
- Liaise with internal stakeholders (R&D, Quality, Clinical) to gather regulatory inputs
- Support communication with Notified Bodies and authorities where required
- Maintain regulatory documentation throughout the product lifecycle
Key Requirements
- Experience in Regulatory Affairs within medical devices
- Solid understanding of MDD and exposure to MDR requirements
- Experience with technical documentation and regulatory submissions
- Ability to work in a developing, hands‑on regulatory environment
- Fluent in both German and English (written and spoken)
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