Regulatory Affairs Specialist - U.S. Market Submissions (Medical Devices)
€60,000-€70,000 | 4 Days/Week in Office | Location: Southwest Germany (Near Tuttlingen) | Urgent Hire

Work with a Global Innovator in Medical Technology

An exciting opportunity has opened at a privately held medical device manufacturer based in southwest Germany. Known for its international reach and strong values, this company blends the stability of an established player with the flexibility of a fast-moving, innovation-driven environment.

They are currently seeking a Regulatory Affairs Specialist with a focus on U.S. market submissions to join their team ASAP.

Key Responsibilities

Lead and manage regulatory submissions for the U.S. market, including full ownership of 510(k) submissions
Coordinate with internal teams to compile technical documentation, clinical evidence, and risk data
Translate EU-based product development into FDA-compliant regulatory strategies
Maintain and update regulatory systems and databases (e.g. FURLS)
Support UDI processes and ensure accurate product identification (e.g. GUDID)
Track and interpret changes in U.S. regulatory requirements and ensure internal alignment

What You'll Bring

3+ Years of experience in Regulatory Affairs in the Medical Device sector
Demonstrated experience completing at least one 510(k) submission
A degree in a relevant scientific or technical field (e.g. life sciences, medical technology)
A proactive, detail-oriented approach to problem-solving
Strong communication skills and the ability to work cross-functionally
Fluency in both German and English

What's on Offer

A permanent role in a resilient and growing industry
Diverse, impactful projects with international scope
A collaborative, forward-thinking work culture
Competitive compensation including bonuses and travel support
Access to health and wellness programs
On-site dining with fresh, seasonal meals

Interested in shaping the future of medical technology?
Apply now to be part of a team where innovation and collaboration drive meaningful impact.