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
In this role, you will develop and implement global regulatory strategies, ensure end‑to‑end regulatory compliance for our products and drive the digitalization of Regulatory Affairs processes, tools and data to support transparent, efficient and compliant business decision‑making.
The role of Senior Expert Regulatory Affairs will involve:
Developing and implementing comprehensive regulatory paths that align with business goals and global regulatory requirements.
Ensuring regulatory compliance of products (including active and non‑active medical devices, software and consumer products) throughout their lifecycle, from market authorization to product discontinuation.
Leading and overseeing regulatory submissions and approvals for key markets (e.g. EU MDR/UK MDR,, 21 CFR21 CF, NMPA, KFDA, TFDA, TGA), including product and facility registrations and labeling compliance.
Acting as a key driver for digital Regulatory Affairs tools and processes (e.g. RIM, eQMS, electronic document management, UDI/registration databases), ensuring data integrity, traceability and efficient regulatory workflows.
Collaborating with internal and external stakeholders (e.g. R&D, Quality, Marketing, Commercial, SSCs, notified bodies and regulatory authorities) and serving as PRRC Deputy for the relevant product portfolio, including responsibilities for EUDAMED and other central registrations.
Your Experience
Degree (BSBS/MScMSc) in Life Sciences, Engineering, Optics, Regulatory Affairs and/or equivalent related experience.
- 5−7 years of experience in Regulatory Affairs and Quality Management, preferably in medical devices and/or pharma, ideally including software as a medical device and IEC 62304IEC 62304.
Proven experience with EU Medical Device Regulation (EU 2017/745)EU 2017/745, ISO 1348513485, MDSAP and working with European notified bodies and competent authorities.
Experience with FDA requirements and successful submissions (e.g. 510(k) ) as well as other international regulators (e.g. NMPA, PMDA, TFDA, TGA or similar).
Strong knowledge of digital Regulatory Affairs systems and tools (e.g. RIM, eQMS, electronic document management, UDI/registration databases) and electronic submissions, combined with excellent communication, project management and stakeholder management skills in an international environment.
It would be desirable if you had:
PRRC certification and/or formal PRRC qualification.
Additional certifications in Life Sciences, Quality or Regulatory Affairs.
Practical experience in designing, improving or automating RA processes using workflow and collaboration tools (e.g. SharePoint, SAP, Power BI or similar).
Your Benefits
If you join ZEISS, you will have access to a range of benefits, including:
Competitive compensation package with performance‑related components and attractive pension provisions.
Flexible working arrangements (e.g. hybrid working where applicable), international collaboration and opportunities for further professional development and training.
Access to comprehensive health and wellbeing offerings, employee discounts and a modern, innovative working environment.
Role Details
Location: Lisbon, Portugal - 2 days on-site, 3 days from home with up to 30% potential international travel
Salary: Competitive and based on experience and qualifications, in line with ZEISS internal frameworks and local market conditions (details to be discussed during the recruitment process).
Apply now to take the next step in joining ZEISS, where you can push technological boundaries, shape markets and contribute to the advancement of society.
Your ZEISS Recruiting Team:
Lameez Peer