Senior Regulatory Affairs Lead — MedTech (Italy)

Biopharma Asia; Pomezia; Remote; EUR 40,000 - 64,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist, Italy, to manage regulatory planning, execution, and compliance across Electrophysiology and Neurovascular businesses. You will coordinate registrations, support market access, and provide guidance on promotional materials while liaising with local authorities and internal teams.

The role requires strong knowledge of EU medical device requirements, 2–4 years in Regulatory Affairs, and fluency in Italian and English.

Qualifications

• In-depth knowledge of EU medical device regulatory requirements and Italian requirements.
• Experience in Regulatory Affairs within medical devices or pharmaceuticals (2–4 years).
• Excellent written and oral communication skills in Italian and English.

Responsibilities

• Act as Regulatory Affairs partner for tender teams, ensuring compliance and managing regulatory documents for tenders and offers.
• Coordinate product registrations/notifications with Italian authorities, maintain Ministry of Health databases and registries.
• Provide regulatory review and guidance for promotional materials, ensuring compliance with regulations and company policies.
• Collaborate with Marketing, Medical Affairs, Quality, and other functions to integrate regulatory requirements into activities.
• Monitor regulatory changes and advise on required actions to maintain compliance.
• Represent Regulatory Affairs in interactions with authorities and industry associations, as assigned.

Skills

Regulatory Affairs Compliance

Regulatory Awareness

Education

Bachelor degree or equivalent in related field

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist, Italy, to manage regulatory planning, execution, and compliance across Electrophysiology and Neurovascular businesses. You will coordinate registrations, support market access, and provide guidance on promotional materials while liaising with local authorities and internal teams.

The role requires strong knowledge of EU medical device requirements, 2–4 years in Regulatory Affairs, and fluency in Italian and English.