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!