Regulatory Affairs Specialist

Castiglione Olona, Varese (3 days on-site - 2 days smart working)

Permanent, Full Time

ZEISS is technology and innovation. Founded in Germany in 1846, we’re an internationally leading technology enterprise operating in the optics and optoelectronics industries generating more than 10.8 billion Euros in revenue with around 46,000 employees across 50 countries around the globe.

As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities. Therefore, 15% of revenue is currently invested in science and R&D. As the pioneer of scientific optics, we continue to challenge the limits of human imagination. With our passion for excellence we create value for our customers and inspire the world to see in new ways. We’re looking for a Regulatory Affairs Expert to join us in Castiglione Olona, Varese.

ZEISS Sun Lens, a division of the globally renowned ZEISS Group, specializes in the development and production of high-quality sun lenses for eyewear. With a strong focus on innovation, optical precision, and premium aesthetics, ZEISS Sun Lens serves leading fashion and sports brands worldwide.

Your Role

The role of Regulatory Affairs Expert be focused on ensuring that ZEISS Sun Lens products meet all legal and regulatory requirements in the countries where they’re sold, especially within the European Union (EU) and to coordinate these efforts with global teams.

Regulatory Compliance: Make sure all lens products follow safety, labeling, and legal regulations, especially related to PPE (Personal Protective Equipment) and MDR (Medical Device Regulation).

• Global Coordination: Work closely with regulatory teams in other regions to keep compliance aligned across all markets.
• Work with Authorities: Act as the main contact for EU regulators. Help handle product approvals, incident reporting, product recalls, and safety actions.
• Maintain Compliance Records:
• Update internal regulatory databases, track approvals, and ensure proper documentation is in place.
• Support Other Departments: Help Supply Chain, Procurement, and Customer Service with regulatory questions — like import issues or chemical safety.
• Marketing & Materials Review: Review advertising and communication materials to ensure they are compliant with regulations.
• Training: Train local staff on regulatory topics and help coordinate global training initiatives.
• Monitor Regulation Changes: Keep up with new or changing laws, and inform the global regulatory team when updates are needed.

Your Experience

As a regulatory Affairs Expert you will have:

• A science degree (preferably in chemistry or materials science)
• 2+ years of experience in regulatory affairs (especially related to PPE or medical devices)
• Strong knowledge of EU and international regulations
• Fluent in Italian and English
• Good with communication, teamwork, and organization
• Comfortable using Microsoft Office tools
• Willing to travel when needed

You will ideally have:

• Experience related to PPE or Medical Devices
• Strong understanding of international regulations (EU, APAC and US)
• Bonus - Production, attendance and participation
• Home working (3 days on site and 2 days smart working available)
• Welfare benefits
• Opportunities for learning & progression

Please consider that you must have a valid right to work in Italy to be considered for this position.

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Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, ideology, disability, age or sexual orientation and identity.