Regulatory Affairs Associate, Medical Devices (EU/FDA)

MED-EL; Innsbruck; On-site; EUR 43,000 - 53,000; Full time

Benefits offered by this job

Central Location

Flexible Hours

International Environment

Language Courses

Onboarding

Workplace Well-Being

Job summary

MED-EL, based in Innsbruck, Austria, seeks a Regulatory Affairs professional for full-time work in our Innsbruck office. The role focuses on ensuring compliance with EU and FDA regulations, providing strategic input to product development, and maintaining registrations and approvals worldwide.

You will prepare submissions, develop regulatory strategies, and coordinate projects with a global team. Fluency in English (C1) and basic German (A2) are required, with a university degree in law,

Qualifications

• University degree, preferably in law, science, or engineering.
• At least 1 year of experience in medical device regulatory affairs, ideally with Regulation (EU) 2017/745 and FDA requirements.
• Excellent written and spoken English (C1 level) required.

Responsibilities

• 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.

Skills

Regulatory affairs

English C1

German A2

Team player

Education

University degree in law/science/engineering

Job description

MED-EL, based in Innsbruck, Austria, seeks a Regulatory Affairs professional for full-time work in our Innsbruck office. The role focuses on ensuring compliance with EU and FDA regulations, providing strategic input to product development, and maintaining registrations and approvals worldwide.

You will prepare submissions, develop regulatory strategies, and coordinate projects with a global team. Fluency in English (C1) and basic German (A2) are required, with a university degree in law,