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.