Regulatory Affairs Associate (m/f/d)
Vor 30+ TagenDas könntest du laut kununu User:innen als Regulatory Affairs Manager:in in Tirol verdienen
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Deine Aufgaben
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.
- 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
Dein Profil
- 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
Vergütung & Benefits
- Central Location
- Flexible Hours
- International Environment
- Language Courses
- Onboarding
- Workplace Well-Being
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 47,810.14.
Über den Arbeitgeber
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.
Bewerbungsprozess
Please apply in English and include a cover letter!
This position is to be filled immediately.
If you have any questions please contact Caroline Schenk. Email >
Regulatory Affairs Associate (m/f/d)
Regulatory Affairs
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
Please apply in English and include a cover letter! Further information about MED-EL can be found here.
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. Email >
About MED-EL
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? Apply now!
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