Your Talent, our Vision – together we see beyond. Your start at ZEISS Vision Care. As a leading manufacturer of ophthalmic lenses, we help people around the world achieve a clearer vision – sustainable and with focus on the future.
Our products are as diverse as the career paths we offer, from tailored lenses to award-winning measurement systems. Become part of our team and shape a future in which clear vision and professional success go hand in hand.
Your Role
As Senior Expert Regulatory Affairs you will be part of Regulatory Affairs team with the following responsibilities:
1. Develop and implement global regulatory pathways for product authorizations
2. Oversee preparation and submission of regulatory documents to authorities
3. Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation and ensure regulatory compliance for product labeling and support clinical trials
4. Lead efforts to obtain necessary approvals and licenses in various markets (e.g., EU MDR, UK MDR)
5. Integrate regulatory elements into business processes to minimize approval delays and rejections
6. Maintain and update regulatory documentation related to Quality Management Systems and assess marketing claims
Your Profile
7. BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs and/or related experience
8. Strong experience in regulatory affairs and quality management, preferably in medical devices, ideally with experience in standalone or embedded medical device software and IEC 62304, or in pharma
9. Understanding and proven track record working with notified bodies and regulatory authorities in Europe
10. Strong knowledge of regulatory requirements and processes in relevant markets combined with advanced project management skills, time and budget management proficiency in an multicultural environment
11. Certifications in ISO 134485, MDSAP, PRRC, any other certification related to Life Science/Regulatory affairs is a plus
12. Experience with FDA requirements and successful submissions (e.g., 510(k) and FDA audits) in addition to knowledge regarding digital processes in RA (incl. submissions, digitalization and intelligence)
13. Strong analytical and problem-solving skills as well as a solid customer and result oriented focus
14. Excellent communication and negotiation skills expressed with fluency in English and German
Your ZEISS Recruiting Team:
Hannah Beutler