Regulatory Affairs Expert – EU/MDR, PPE, Hybrid

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

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.