Regulatory Affairs Expert

ZEISS Group; Castiglione Olona; Hybrid; EUR 41,000 - 53,000; Full time

Benefits offered by this job

Salary range £35,000 - £45,000

Bonus – Production, attendance and ???

Home working (3 days on site and 2 on)

Subsidized Canteen

Welfare Benefits

Job summary

ZEISS Sun Lens in Castiglione Olona, Varese is seeking a Regulatory Affairs Expert to ensure products meet EU and international regulations, coordinating with global teams.

You will handle regulatory compliance for PPE and Medical Devices, liaise with EU regulators, maintain records, train staff, and support other departments with regulatory questions. Fluent Italian and English, science degree, 2+ years experience, and willingness to travel are required.

Qualifications

• A science degree (preferably in chemistry or materials science).
• 2+ years of experience in regulatory affairs (PPE or medical devices).
• Strong knowledge of EU and international regulations.
• Fluent in Italian and English.
• Willing to travel.

Responsibilities

• Ensure lens products meet safety, labeling, and regulatory requirements (PPE & MDR).
• Coordinate with regional/regulatory teams to align compliance.
• Act as main contact for EU regulators and manage approvals, incidents, recalls, and safety actions.
• Maintain compliance records and update regulatory databases.
• Review marketing materials for regulatory compliance.
• Train local staff and coordinate global regulatory training.
• Monitor regulation changes and inform global team.

Skills

Communication

Teamwork

Organization

Microsoft Office

Travel readiness

Education

Science degree (chemistry or materials science)

Tools

Microsoft Office

Job description

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. 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.

About ZEISS Sun Lens

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)

Our Benefits

• Salary: £35,000 - £45,000
• Bonus – Production, attendance and participation
• Home working (3 days on site and 2 days smart working available.
• Subsidized Canteen
• Welfare Benefits

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.