IT & Softwareentwickler Stellenangebote in Deutschland
Team Leader, External Devices and Software (m/f/d)
46.781 - 46.781 €
MED-EL Medical Electronics
Fürstenweg, Innsbruck
46.781 - 46.781 €
Anforderungen
Muss:
- Bachelor's degree or higher 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.
Technologien
Verantwortlichkeiten
- 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.
Beschreibung
At MED-EL, we are 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, we have over 3,000 employees around the world. Our Regulatory Affairs department ensures that products comply with applicable regulations and standards, providing strategic input to product developments, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes to ensure continued compliance. We offer a central location, employee discounts, flexible hours, an international environment, onboarding, and a focus on workplace well-being. The minimum salary will be determined based on professional experience, with a formal minimum salary according to the Collective Bargaining Agreement set at €46,781.00.
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