Regulatory Affairs Associate (m/f/d)

MED-EL Elektromedizinische Geräte Deutschland GmbH; Innsbruck; Hybrid; EUR 43,000 - 53,000; Full time

Benefits offered by this job

Central Location

Flexible Hours

International Environment

Language Courses

Onboarding

Job summary

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.

Qualifications

• 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.

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 or science or engineering

Job description

Our Regulatory Affairs department ensures that products comply with applicable regulations and standards. This includes providing strategic input to product developments, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes to ensure continued compliance.

Your Tasks

• 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

Your Profile

• 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
• Basic German skills (A2 level) required
• Strong team player with high motivation, attention to detail, and reliability

Central Location

Flexible Hours

International Environment

Language Courses

Onboarding

Further information

Minimum Salary

Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 47,810.14.

Earliest Entry Date

This position is to be filled immediately.

Your Contact Person

If you have any questions please contact Caroline Schenk.