Regulatory Affairs Expert

Carl Zeiss; Varese; Ibrido; EUR 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary based on skills and

Descrizione del lavoro

Carl Zeiss seeks a Regulatory Affairs Expert to ensure Sun Lens products meet EU and global requirements. You will coordinate with regional teams, act as the primary contact for EU regulators, and manage approvals, recalls and safety actions.

You will maintain regulatory databases, train staff, monitor changes, and align compliance across markets to deliver safe, compliant products.

Competenze

• 2+ years of regulatory affairs experience, PPE or medical devices.
• Strong knowledge of EU and international regulations.
• Fluent in Italian and English.
• Willing to travel.

Mansioni

• Act as main contact for EU regulators; manage approvals, incidents, recalls and safety actions.
• Coordinate with global regulatory teams to harmonize requirements across markets.
• Maintain regulatory databases and document control; track approvals.
• Review marketing materials for regulatory compliance.
• Provide training on regulatory topics and coordinate global training.
• Monitor regulatory changes and inform the global team.

Conoscenze

Regulatory knowledge (PPE and medicals

Formazione

Science degree (chemistry or materials science)

Strumenti

Microsoft Office

Descrizione del lavoro

As Regulatory Affairs Expert, you ensure ZEISS Sun Lens products meet EU and global requirements, coordinating with regional teams. You will act as the primary contact for EU regulators and manage product approvals, recalls, and safety actions. The role involves maintaining regulatory records, advising other departments, and training staff on regulatory topics. You will monitor regulatory changes and align global compliance across markets, enabling safe, compliant product delivery.

• Competitive salary based on skills and experience


• Bonus – Production, attendance and participation


• Home working (3 days on site and 2 days smart working)


• Ensure regulatory compliance for lens products in EU and other regions, focusing on PPE and MDR


• Coordinate with global regulatory teams to harmonize requirements across markets


• Act as main contact for EU regulators; manage approvals, incident reports, recalls, and safety actions


• Maintain regulatory databases and document control; track approvals


• Support Supply Chain, Procurement, and Customer Service with regulatory queries (import issues, chemical safety)


• Review marketing and communications materials for regulatory compliance


• Provide training on regulatory topics and coordinate global training efforts


• Monitor regulatory changes and inform global team of updates


• Science degree (preferably in chemistry or materials science)


• 2+ years of regulatory affairs experience (PPE or medical devices)


• Strong knowledge of EU and international regulations


• Fluent in Italian and English


• Good communication, teamwork, and organizational skills


• Proficient with Microsoft Office


• Willing to travel


• communication


• teamwork


• organization


• Regulatory knowledge (PPE and medical devices)


• EU and international regulations


• Microsoft Office

Regulatory Affairs Expert varese, lombardia, it