Regulatory Affairs Manager – Global XRX Business

About the role

ZEISS is seeking a Regulatory Affairs Manager to support the growth and innovation of its global XRX business from Lisbon. You will act as the primary liaison between the XRX Strategic Business Unit and the VIS Global Regulatory Affairs team, ensuring regulatory excellence across worldwide markets.

Key responsibilities

• Develop and maintain the XRX regulatory affairs strategy aligned with ZEISS objectives.
• Coordinate regulatory activities for open‑market and custom‑solution projects with the global team.
• Define regulatory requirements, registration pathways, and strategies for new product developments.
• Lead product registrations, regulatory submissions, and documentation reviews.
• Ensure compliance with EU MDR (2017/745), FDA 510(k) requirements, MDSAP and other relevant international standards.
• Monitor global regulatory developments for AR/VR and Smart Glasses technologies and assess impact on the product portfolio.
• Provide regulatory guidance to internal stakeholders throughout product development and lifecycle.
• Serve as the main regulatory contact for customers, authorities, and audit activities.
• Support post‑market surveillance, regulatory communications, audit preparation and CAPA follow‑up.

Required profile

• Holder of a Bachelor’s or Master’s degree in a relevant field (e.g., regulatory affairs, life sciences, engineering).
• Proven experience in regulatory affairs for medical devices or related technologies.
• Strong knowledge of EU MDR, FDA 510(k) processes and MDSAP.

Required skills

• EU MDR (2017/745) compliance
• FDA 510(k) submission expertise
• MDSAP knowledge
• Regulatory strategy development
• Product registration and documentation review
• Post‑market surveillance and CAPA management