Senior Expert Regulatory Affairs (m/f/x)

ZEISS Vision Care is a leading manufacturer of ophthalmic lenses, and we are seeking a Senior Expert Regulatory Affairs to join our team. The successful candidate will be responsible for developing and implementing global regulatory pathways, overseeing regulatory document submissions, and ensuring compliance throughout the product lifecycle.

Requirements

• BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs and/or related experience
• Strong experience in regulatory affairs and quality management
• Understanding and proven track record working with notified bodies and regulatory authorities in Europe
• Certifications in ISO 13485, MDSAP, PRRC, and other Life Science/Regulatory affairs certifications
• Experience with FDA requirements and successful submissions