Hybrid Regulatory Affairs Expert – EU MDR & PPE

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

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.