Regulatory Affairs Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/80ti65

ppbCastiglione Olona, Varese (3 days on-site - 2 days smart working) /b /ppbPermanent, Tempo pieno /b /ppZEISS is technology and innovation.
Founded in Germany in ****, 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.
/ppAs 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 RD.
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.
/ppZEISS 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.
/ph3Your Role /h3pThe 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.
/ppRegulatory Compliance: Make sure all lens products follow safety, labeling, and legal regulations, especially related to PPE (Personal Protective Equipment) and MDR (Medical Device Regulation).
/pulliGlobal Coordination: Work closely with regulatory teams in other regions to keep compliance aligned across all markets.
/liliWork with Authorities: Act as the main contact for EU regulators.
Help handle product approvals,



incident reporting, product recalls, and safety actions.
/liliMaintain Compliance Records: /liliUpdate internal regulatory databases, track approvals, and ensure proper documentation is in place.
/liliSupport Other Departments: Help Supply Chain, Procurement, and Customer Service with regulatory questions — like import issues or chemical safety.
/liliMarketing Materials Review: Review advertising and communication materials to ensure they are compliant with regulations.
/liliTraining: Train local staff on regulatory topics and help coordinate global training initiatives.
/liliMonitor Regulation Changes: Keep up with new or changing laws, and inform the global regulatory team when updates are needed.
/li /ulh3Your Experience /h3pAs a regulatory Affairs Expert you will have: /pulliA science degree (preferably in chemistry or materials science) /lili2+ years of experience in regulatory affairs (especially related to PPE or medical devices) /liliStrong knowledge of EU and international regulations /liliFluent in Italian and English /liliGood with communication, teamwork, and organization /liliComfortable using Microsoft Office tools /liliWilling to travel when needed /li /ulh3You will ideally have: /h3ulliExperience related to PPE or Medical Devices /liliStrong understanding of international regulations (EU, APAC and US) /liliBonus - Production, attendance and participation /liliHome working (3 days on site and 2 days smart working available) /liliWelfare benefits /liliOpportunities for learning progression /li /ulpPlease consider that you must have a valid right to work in Italy to be considered for this position.
/p pDiversity 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.
/p /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/80ti65