Engineering

Regulatory Affairs Specialist (USA Focus)

  • Location

    Tuttlingen

  • Sector:

    Quality, Medical Devices

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Max Jones

  • Contact email:

    m.jones@ioassociates.eu

  • Job ref:

    BBBH161091_1748959664

  • Startdate:

    ASAP

Regulatory Affairs Expert - Medical Device Approval (USA Focus)

Join a global medical technology company that combines the innovation of a start-up with the stability of a market leader. As a family-owned business with an international presence, we develop solutions that help health care professionals focus on patient care.

Your Role

  • Manage U.S. regulatory approvals for medical devices (e.g., 510(k) submissions).
  • Maintain registration databases (FURLS) and support U.S. regulatory contacts.
  • Assist with UDI (GUDID) compliance and monitor regulatory changes.

Your Profile

  • Degree in engineering, life sciences, or a related field.
  • Experience in regulatory affairs within Medical Devices
  • Proactive, detail-oriented, and collaborative.
  • Fluent in German and English.

What We Offer

  • A secure role in a future-proof industry.
  • Innovative projects and a modern work environment.
  • Competitive salary with bonuses and travel allowance.

If you're passionate about regulatory affairs and want to help shape the future of medical technology, we'd love to hear from you. Apply now and become part of a team that values innovation, collaboration, and purpose.