Senior Expert Regulatory Affairs (m/f/x)

<p><b>Your Talent, our Vision – together we see beyond. Your start at ZEISS Vision Care. </b>As a leading manufacturer of ophthalmic lenses, we help people around the world achieve a clearer vision – sustainable and with focus on the future. </p><p>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.</p><p></p><h1><b>Your Role</b></h1><p><span>As Senior Expert Regulatory Affairs you will be part of Regulatory Affairs team with the following responsibilities: </span></p><ul><li><p>Develop and implement global regulatory pathways for product authorizations</p></li><li><p>Oversee preparation and submission of regulatory documents to authorities</p></li><li><p>Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation and ensure regulatory compliance for product labeling and support clinical trials</p></li><li><p>Lead efforts to obtain necessary approvals and licenses in various markets (e.g., EU MDR, UK MDR)</p></li><li><p>Integrate regulatory elements into business processes to minimize approval delays and rejections</p></li><li><p>Maintain and update regulatory documentation related to Quality Management Systems and assess marketing claims</p></li></ul><p></p><p></p><h1><b>Your Profile</b></h1><ul><li><p><span>BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs and/or related experience </span></p></li><li><p><span>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</span></p></li><li><p><span>Understanding and </span>proven track record <span>working with notified bodies and regulatory authorities in Europe</span></p></li><li><p><span>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</span></p></li><li><p><span>Certifications in ISO 134485, MDSAP, PRRC</span>, a<span>ny other certification related to Life Science/Regulatory affairs is a plus</span></p></li><li><p><span>Experience with FDA requirements and successful submissions (e.g., 510(k) and FDA audits) in addition to knowledge regarding </span>digital processes in RA (incl. submissions, digitalization and intelligence)</p></li><li><p><span>Strong analytical and problem-solving skills</span> as well as a s<span>olid customer and result oriented focus </span></p></li><li><p><span>Excellent communication and negotiation skills expressed with fluency in English and German</span></p></li></ul><p></p><p>Your ZEISS Recruiting Team:</p>Hannah Beutler