We're supporting a global MedTech leader in their search for a freelance Regulatory Affairs Consultant with expertise in U.S. market approvals.

This is a high-impact contract role within a future-oriented industry, ideal for professionals looking to apply their regulatory knowledge to meaningful international projects, particularly related to the U.S. market.

Key responsibilities include:

Preparing and managing 510(k) submissions for FDA clearance
Handling FURLS registrations and liaising with U.S. regulatory bodies
Overseeing UDI (GUDID) compliance and tracking relevant regulatory developments

Requirements:

Degree in life sciences, engineering, or a related field
Experience working with Class II medical devices
Familiarity with 510(k) submissions
Strong communication skills and an independent, detail-oriented work style
Fluency in German and English

If you are a freelancer with the right to work in Germany and are available for a new project, feel free to get in touch directly or forward this to someone who may be interested.