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 3,000 employees around the world.
RA_32510
Team Leader, External Devices & Software (m/f/d)
Regulatory Affairs
Innsbruck, Austria
Professionals Full-Time 38.5h Limited 31-Mar-2028
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.
* Drive regulatory strategy for new product launches, ensuring proactive and effective planning aligned with global requirements
* Lead a team of regulatory experts in External Devices & Software within Regulatory Affairs
* Act as a key contributor to product development as a member of the Design Control Board (DCB), supporting breakthrough innovations from concept to market
* Anticipate and adapt to evolving regulatory landscapes by monitoring changes in standards and regulations, and preparing the business for seamless transitions
* Lead global submissions and approvals, with primary responsibility for regulatory filings in the EU, US, Canada, China, and additional markets as assigned
* Bachelor's degree or higher degree (University, FH) in Biomedical Engineering, Life Sciences, or a related field
* Proven experience in Regulatory Affairs within the Medtech industry, with a strong understanding of global compliance requirements
* Previous leadership and strategic planning experience is highly desired
* Very good English skills, both written and spoken as well as proficiency in German
* Proactive mindset, reliability, and a motivated, “can-do” attitude that thrives in a collaborative environment
* Central Location
* Employee Discounts
* Flexible Hours
* International Environment
* Onboarding
* Workplace Well-Being
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
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