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)