Informationen zur Anzeige:
Team Leader, External Devices & Software (m/f/d)
Innsbruck (Österreich)
Aktualität: 04.11.2025
Anzeigeninhalt:
04.11.2025, MED-EL Medical Electronics
Innsbruck (Österreich)
Team Leader, External Devices & Software (m/f/d)
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.
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
Qualifikationen:
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
Berufsfeld
Pharma, Chemie, Med., Biotechn.
Technische Berufe, Ingenieurwesen
Fertigung, Inbetriebn., Qualitätsw.
Qualitätswesen, Zulassung
Medizintechnik
Qualitätswesen, Prüfung
Techn. Entwicklung, Konstruktion
Standorte
