Senior Expert Regulatory Affairs

Job description

ZEISS is technology and innovation. Founded in Germany, in 1846, ZEISS is an internationally leading technology enterprise operating in the optics and optoelectronics industries across 50 countries. As a company wholly owned by a foundation, ZEISS is committed to responsibility in all its activities. As a pioneer in scientific optics, it's employees across the globe continue to push the boundaries of what is possible. With a strong focus on quality and innovation, ZEISS creates value for its customers and helps shape new ways of seeing the world. We’re looking for a Senior Expert Regulatory Affairs to join us in Aalen, Germany (with global collaboration and up to 30% travel, depending on location). Operating within the Global Quality, Regulatory and EHS organization for Carl Zeiss Vision, you will support worldwide regulatory compliance and product approvals for a diverse portfolio of medical devices, software and consumer products. Your Role Develop and oversee regulatory pathways and strategies to ensure timely market access. Prepare, submit and manage regulatory documentation and approvals (e.g. EU MDR, UK MDR, FDA 510(k), other international regulators). Ensure regulatory compliance of products and labeling throughout their lifecycle and support clinical trials in EMEA. Drive the digitalization of Regulatory Affairs (e.g. RIM, eQMS, electronic document management, UDI/registration databases). Collaborate with internal and external stakeholders and contribute to the Regulatory network in EMEA; act as PRRC Deputy where applicable. Your Profile BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs or related field. Strong experience in Regulatory Affairs and Quality Management, preferably in medical devices, ideally including software (IEC 62304). Proven experience with EU MDR, ISO 13485, MDSAP and working with European notified bodies and authorities. Experience with FDA submissions (e.g. 510(k)) and other international regulators (e.g. NMPA, PMDA, TFDA, TGA). Confident user of digital RA tools and electronic submissions; experience in RA process digitalization is a plus. Strong analytical, project management and stakeholder management skills; fluent in English. PRRC and/or additional Quality/RA certifications are an advantage. Your Benefits Competitive salary aligned with experience, ZEISS frameworks and local market. Health & Life Insurance, meal allowance (€10.20/day) and annual flex benefits budget (e.g. gym, transport, health). 28 vacation days and discounts on ZEISS lenses for you and your direct family. Flexible hybrid working model, international collaboration and extensive learning & development opportunities. Wellbeing programs, including family‑friendly flexibility and free support (legal, psychological, nutrition, etc.). Apply now to join ZEISS in Lisbon and help shape the future of vision and medical technology. Your ZEISS Recruiting Team: Lameez Peer