Senior Regulatory Affairs Specialist, MedTech Italy

Johnson & Johnson MedTech; Pomezia; Sur place; EUR 40 000 - 64 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Healthcare coverage

Résumé du poste

Johnson & Johnson MedTech in Italy is seeking a Senior Regulatory Affairs Specialist to implement regulatory plans for new and existing products, focusing on Italian requirements and market access. You will coordinate registrations, maintain regulatory databases, and guide marketing and cross-functional teams to ensure compliant commercialization of Electrophysiology and Neurovascular devices.

The role emphasizes collaboration with authorities and internal stakeholders, regulatory strategy for

Qualifications

• Bachelor degree or equivalent required.
• 2–4 years in Regulatory Affairs or related field in medical devices or pharmaceutical industries.
• Excellent written and spoken Italian and English.

Responsabilités

• Serve as the primary Regulatory Affairs partner for tender activities, ensuring regulatory documentation for public tenders and private offers.
• Coordinate product registrations and notifications with Italian authorities and maintain national registries.
• Provide regulatory review and guidance for promotional and non-promotional materials, ensuring compliance with regulations and Johnson & Johnson policies.
• Collaborate with Marketing, Quality, Supply Chain and other functions to integrate regulatory requirements into business processes.
• Monitor Italian regulatory changes and support implementation of necessary actions.
• Represent Regulatory Affairs in interactions with industry associations and authorities; maintain inspection-ready documentation.

Connaissances

Regulatory compliance

Regulatory awareness

Cross-functional collaboration

Strong communication

Formation

Bachelor's degree or equivalent

Description du poste

Johnson & Johnson MedTech in Italy is seeking a Senior Regulatory Affairs Specialist to implement regulatory plans for new and existing products, focusing on Italian requirements and market access. You will coordinate registrations, maintain regulatory databases, and guide marketing and cross-functional teams to ensure compliant commercialization of Electrophysiology and Neurovascular devices.

The role emphasizes collaboration with authorities and internal stakeholders, regulatory strategy for