Regulatory Affairs Manager - US Focus

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

What's on Offer

Interested in shaping the future of medical technology?

Apply now to be part of a team where innovation and collaboration drive meaningful impact.