Talent.com
Diese Stelle ist in deinem Land nicht verfügbar.
Regulatory Affairs Manager - US Focus

Regulatory Affairs Manager - US Focus

iO Associates - UK / EUTuttlingen, Baden-Württemberg, Germany
Vor einem Tag
Stellenbeschreibung

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.

    Jobalert für diese Suche erstellen

    Regulatory Manager • Tuttlingen, Baden-Württemberg, Germany