Senior Regulatory Affairs Specialist, Italy

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8p54s6

Johnson & Johnson seeks a Senior Regulatory Affairs Specialist in Pomezia, Italy to manage regulatory compliance and market access for medical devices in Electrophysiology and Neurovascular. The role involves coordinating product registrations, tender submissions, and interactions with Italian authorities while supporting cross-functional commercialization activities.
Responsibilities
Serve as primary regulatory partner for tender team, ensuring compliance and managing regulatory documentation for public tenders and private offers
Coordinate product registrations, notifications, and Ministry of Health database submissions for Italian market access and lifecycle maintenance
Perform regulatory assessments, coordinate approvals, and liaise with local authorities and internal stakeholders on registrations and renewals
Monitor and interpret evolving Italian regulatory requirements, assess business impact,



and support implementation of compliance actions
Provide regulatory guidance on promotional materials and collaborate with Marketing, Medical Affairs, Quality, and Supply Chain on regulatory integration
Requirements
Bachelor's degree or equivalent qualification
2–4 years' regulatory affairs or related experience in medical device or pharmaceutical sectors
In-depth knowledge of EU medical device regulations and Italian requirements
Fluent written and oral communication in Italian and English
Strong collaboration and partnership-building abilities
Results-oriented mindset with ability to work in matrixed organizations
Compensation:
€39,800–€64,055 base

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8p54s6