Beschreibung
Limited until 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.
Your Tasks
Drive regulatory strategy for new product launches, ensuring proactive and effective planning aligned with global requirements...
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Limited until 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.
Your Tasks
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
Your Profile
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
Full-time post 38,5 hours per week, limited until 31-Mar-2028, flexible working time model with core working hours, details will be discussed in a personal interview.
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
https://jobs.medel.com/EN/open-position/RA_32510/online
A personal interview is only possible after prior invitation from the HR department.