Regulatory Affairs Expert

Carl Zeiss Vision Italia S.p.A.; Castiglione Olona; Hybrid; EUR 41,000 - 53,000; Full time

Benefits offered by this job

Home working 3 days onsite / 2 days HW

Bonus – Production, attendance and参与

Subsidized canteen

Job summary

ZEISS Sun Lens, a division of the ZEISS Group, seeks a Regulatory Affairs Expert in Castiglione Olona to ensure compliance across EU markets and coordinate with global teams.

The ideal candidate has a science degree, 2+ years in regulatory affairs (PPE/medical devices), fluent Italian and English, and willingness to travel. Hybrid work: 3 days on site, 2 days smart working. Salary £35,000–£45,000 with a bonus and welfare benefits.

Qualifications

• As a Regulatory Affairs Expert, you will ensure PPE and MDR compliance.
• You will liaise with EU regulators and global teams to maintain alignment.
• You will manage regulatory documentation and training duties.

Responsibilities

• Ensure that lens products meet safety, labeling, and regulatory requirements.
• Coordinate with regulatory teams across regions for compliance.
• Serve as the main contact for EU regulators and handle approvals and incidents.
• Maintain regulatory databases and document control.
• Support other departments with regulatory questions and import issues.
• Review marketing materials for regulatory compliance.
• Train local staff and coordinate global regulatory training.

Skills

Regulatory affairs

Regulatory compliance

Communication

Teamwork

Fluent Italian

Fluent English

Willing to travel

Microsoft Office

Education

Science degree (chemistry or materials science preferred)

Tools

Microsoft Office

Job description

Regulatory Affairs Expert 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.

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.

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

Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today. Inspire people tomorrow.