Senior Expert Regulatory Affairs (m/f/x)

Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.

In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application silence of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Apply now! It takes less than 10 minutes.

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 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.

As Senior Expert Regulatory Affairs you will be part of Regulatory Affairs team with the following responsibilities: Develop and implement global regulatory pathways for product authorizations

Oversee preparation and submission of regulatory documents to authorities

Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation and ensure regulatory compliance for labeling and support clinical trials

Lead efforts to obtain necessary approvals and licenses in various markets (e.g., EU MDR, UK MDR)

Integrate regulatory elements into business processes to minimize approval delays and rejections

Maintain and update regulatory documentation related to Quality Management Systems and assess marketing claims

BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs and/or related experience

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

Understanding and proven track working with notified bodies and regulatory authorities in Europe

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

Certifications in ISO 134485, MDSAP, PRRC, any other certification related to Life Science/Regulatory affairs is a plus

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)

Strong analytical and problem-solving skills as well as a solid customer and result oriented focus

Excellent communication and negotiation skills expressed with fluency in English and German