Global Regulatory Affairs Associate — Flexible Hours

MED-EL Elektromedizinische Geräte Deutschland GmbH; Innsbruck; Hybrid; EUR 43.000 - 53.000; Vollzeit

Benefits dieser Stelle

Central Location

Flexible Hours

International Environment

Language Courses

Onboarding

Zusammenfassung

MED-EL Elektromedizinische Geräte Deutschland GmbH in Innsbruck, Austria, is seeking a Regulatory Affairs professional to prepare and submit applications and guide regulatory strategies for medical devices worldwide.

The role requires a university degree in law, science, or engineering, at least 1 year in medical device regulatory affairs, and strong English; German basics are required. The position offers a central location, flexible hours, and an international environment.

Qualifikationen

• Minimum 1 year of experience in medical device regulatory affairs.
• Ideally familiar with Regulation (EU) 2017/745 and FDA requirements.
• Excellent written and spoken English (C1) required.
• Basic German skills (A2) required.

Aufgaben

• Prepare and submit applications to international regulatory authorities for product and change approvals.
• Provide regulatory inputs to product development projects.
• Develop regulatory strategies for changes and new products worldwide.
• Lead or coordinate regulatory projects, tasks or compliance initiatives.

Kenntnisse

Regulatory affairs

English (C1)

German (A2)

Team player

Ausbildung

University degree in law or science or engineering

Jobbeschreibung

MED-EL Elektromedizinische Geräte Deutschland GmbH in Innsbruck, Austria, is seeking a Regulatory Affairs professional to prepare and submit applications and guide regulatory strategies for medical devices worldwide.

The role requires a university degree in law, science, or engineering, at least 1 year in medical device regulatory affairs, and strong English; German basics are required. The position offers a central location, flexible hours, and an international environment.