Regulatory Affairs Specialist (USA Focus)

iO Associates - UK/EU; Tuttlingen; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading global medical technology company is seeking a Regulatory Affairs Expert focused on U.S. medical device approvals. This role involves managing regulatory submissions, maintaining compliance databases, and supporting regulatory contacts. The ideal candidate will have a degree in a relevant field, experience in regulatory affairs, and be fluent in both German and English. Enjoy a secure position in a dynamic industry with innovative projects and a competitive salary.

Leistungen

Competitive salary with bonuses

Travel allowance

Innovative projects and modern work environment

Qualifikationen

• Expertise in regulatory affairs within medical devices required.
• Fluent in German and English.

Aufgaben

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

Kenntnisse

Attention to detail

Proactivity

Collaboration

Ausbildung

Degree in engineering, life sciences, or related field

Jobbeschreibung

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.