Jobbeschreibung
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 regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
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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.
As Senior Expert Regulatory Affairs you will be part of Regulatory Affairs team with the following responsibilities:
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Develop and implement global regulatory pathways for product authorizations
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Oversee preparation and submission of regulatory documents to authorities
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Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation and ensure regulatory compliance for product labeling and support clinical trials
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Lead efforts to obtain necessary approvals and licenses in various markets (e.g., EU MDR, UK MDR)
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Integrate regulatory elements into business processes to minimize approval delays and rejections
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Maintain and update regulatory documentation related to Quality Management Systems and assess marketing claims
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BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs and/or related experience
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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
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Understanding and proven track record working with notified bodies and regulatory authorities in Europe
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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
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Certifications in ISO 134485, MDSAP, PRRC, any other certification related to Life Science/Regulatory affairs is a plus
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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)
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Strong analytical and problem-solving skills as well as a solid customer and result oriented focus
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Excellent communication and negotiation skills expressed with fluency in English and German