Italy Senior Regulatory Affairs Specialist — Market Access

Brighter Signals; Pomezia; Hybrid; EUR 40,000 - 64,000; Full time

Benefits offered by this job

Annual bonus

Well-being programs

Insurance plans

Job summary

Johnson & Johnson Medical s.p.a. seeks a Senior Regulatory Affairs Specialist for Italy, focusing on Electrophysiology and Neurovascular products. You will implement regulatory plans and coordinate submissions to ensure compliant commercialization, partnering with marketing and quality teams.

The role requires 2–4 years in regulatory affairs in medical devices or pharma, fluency in Italian and English, and a university degree. Hybrid collaboration across departments is expected.

Qualifications

• University degree and understanding of EU medical device regulatory requirements.
• Readiness to interpret Italian requirements and apply them to activities.
• Excellent written and oral communication in Italian and English.

Responsibilities

• Act as RA partner for tender teams, ensuring regulatory compliance for public/private offers.
• Coordinate product registrations and notifications with Italian authorities and registries.
• Provide regulatory reviews for promotional materials and liaise with internal stakeholders.
• Support regulatory strategy for launches, lifecycle management, and market access.
• Maintain inspection-ready regulatory documentation and participate in audits.

Skills

Regulatory Affairs Compliance

Regulatory Awareness

Education

Bachelor degree or equivalent

Job description

Johnson & Johnson Medical s.p.a. seeks a Senior Regulatory Affairs Specialist for Italy, focusing on Electrophysiology and Neurovascular products. You will implement regulatory plans and coordinate submissions to ensure compliant commercialization, partnering with marketing and quality teams.

The role requires 2–4 years in regulatory affairs in medical devices or pharma, fluency in Italian and English, and a university degree. Hybrid collaboration across departments is expected.