Italy Senior Regulatory Affairs – MedTech & Tender

Johnson & Johnson Co.; Pomezia; On-site; EUR 40,000 - 64,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Insurance plans

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist for Italy, focusing on the Electrophysiology and Neurovascular businesses. You will coordinate regulatory submissions, ensure compliance, and support market access strategies in Italy.

Based in Pomezia, your work will involve cross-functional collaboration with Marketing, Quality, and Supply Chain to deliver timely, compliant product registrations and tender qualifications across Italian authorities.

Qualifications

• Bachelor degree or equivalent required.
• 2–4 years in Regulatory Affairs in med devices or pharmaceutical industries.
• Excellent written and oral communications skills in Italian and English.

Responsibilities

• Act as the primary Regulatory Affairs partner for Tender team, ensuring tender compliance and supporting preparation, review, and maintenance of regulatory documentation.
• Coordinate product registrations and notifications in line with Italian regulatory requirements, including submissions and maintenance of Ministry of Health databases.
• Perform regulatory assessments and coordinate approvals for registrations, renewals, amendments, and market access activities.
• Provide regulatory review and guidance for promotional and non-promotional materials, ensuring compliance with regulations and Johnson & Johnson policies.
• Collaborate with Marketing, Customer Care, Medical Affairs, Quality, Supply Chain and other functions to integrate regulatory requirements into business activities.
• Monitor and interpret new Italian regulatory requirements, assess business impact, and support implementation of necessary actions.
• Represent Regulatory Affairs in interactions with industry associations and Italian Competent Authorities.

Skills

Regulatory knowledge

Communication skills

Collaboration

English proficiency

Italian proficiency

Education

University Bachelor degree or equivalent

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist for Italy, focusing on the Electrophysiology and Neurovascular businesses. You will coordinate regulatory submissions, ensure compliance, and support market access strategies in Italy.

Based in Pomezia, your work will involve cross-functional collaboration with Marketing, Quality, and Supply Chain to deliver timely, compliant product registrations and tender qualifications across Italian authorities.