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
1. Lead and manage regulatory submissions for the U.S. market, including full ownership of 510(k) submissions
2. Coordinate with internal teams to compile technical documentation, clinical evidence, and risk data
3. Translate EU-based product development into FDA-compliant regulatory strategies
4. Maintain and update regulatory systems and databases (e.g. FURLS)
5. Support UDI processes and ensure accurate product identification (e.g. GUDID)
6. Track and interpret changes in U.S. regulatory requirements and ensure internal alignment
What You'll Bring
7. 3+ Years of experience in Regulatory Affairs in the Medical Device sector
8. Demonstrated experience completing at least one 510(k) submission
9. A degree in a relevant scientific or technical field (e.g. life sciences, medical technology)
10. A proactive, detail-oriented approach to problem-solving
11. Strong communication skills and the ability to work cross-functionally
12. Fluency in both German and English
What's on Offer
13. A permanent role in a resilient and growing industry
14. Diverse, impactful projects with international scope
15. A collaborative, forward-thinking work culture
16. Competitive compensation including bonuses and travel support
17. Access to health and wellness programs
18. 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.