Regulatory Affairs Associate (m/f/d)

MED-EL; Innsbruck; Vor Ort; EUR 43.000 - 53.000; Vollzeit

Benefits dieser Stelle

Central Location

Flexible Hours

International Environment

Language Courses

Onboarding

Workplace Well-Being

Zusammenfassung

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,

Qualifikationen

• 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.

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/science/engineering

Jobbeschreibung

RA_12609

Innsbruck, Austria

Professionals

Full-Time 38.5 h

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

Your Benefits

• Central Location
• Flexible Hours
• International Environment
• Language Courses
• Onboarding
• Workplace Well-Being

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.

MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 3,300 employees around the world.

Want to join a company that helps bring the joy of sound to people with hearing loss?

Further information about MED-EL can be found here.