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)