Regulatory Affairs Manager

Regulatory Affairs Manager – Medical Devices

Shape regulatory strategy, influence product design, and help bring innovative medical devices to market – all from the heart of Berlin’s life‑sciences and tech ecosystem.

This is a senior individual contributor role for a Regulatory Affairs Manager who wants real ownership, visibility, and influence. You’ll work at the centre of product development and market access, partnering closely with international customers, notified bodies, and internal leadership to enable global approvals.

Your impact:

• Own and lead regulatory activities for international medical device approvals, including EU conformity assessments and market registrations.
• Act as a key decision maker reviewing and approving technical documentation, declarations of conformity, and compliance evidence.
• Influence design control, risk management, clinical evaluation, usability, and change management as part of the product lifecycle.
• Provide authoritative regulatory guidance across standards such as sterilisation validation, biocompatibility, electrical safety, labelling, and software documentation.
• Represent the organisation in interactions with customers, notified bodies, and regulatory authorities.
• Play a pivotal role in audits, post market activities, and the ongoing development of the quality management system.
• Act as a regulatory reference point within the business, mentoring colleagues and supporting knowledge development.

What you bring:

• A strong regulatory affairs background within the medical device environment.
• Deep understanding of EU medical device regulations and manufacturing processes.
• Confidence operating autonomously on complex topics with minimal supervision.
• A structured, analytical mindset combined with pragmatic decision making.
• Clear communication skills and the ability to influence across functions.
• Fluency in English; German language skills are advantageous.
• Openness to occasional international travel.

Why this role?

You’ll join a forward thinking, ambitious organisation where regulatory expertise is valued as a strategic asset – not a back‑office function. Expect autonomy, meaningful responsibility, and the chance to make visible contributions from one of Europe’s most exciting innovation hubs.