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 sectorDemonstrated experience completing at least one 510(k) submissionA degree in a relevant scientific or technical field (e.g. life sciences, medical technology)A proactive, detail-oriented approach to problem-solvingStrong communication skills and the ability to work cross-functionallyFluency in both German and EnglishWhat's on Offer
A permanent role in a resilient and growing industryDiverse, impactful projects with international scopeA collaborative, forward-thinking work cultureCompetitive compensation including bonuses and travel supportAccess to health and wellness programsOn-site dining with fresh, seasonal mealsInterested in shaping the future of medical technology?
Apply now to be part of a team where innovation and collaboration drive meaningful impact.