Senior Regulatory Affairs Specialist, Italy

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Pomezia, Roma, Italy
Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at : The Senior Regulatory Affairs Specialist, Italy, implements methods for planning, coordinating and delivering regulatory affairs activities for new and existing products, helping to ensure that products distributed by Johnson & Johnson Medical s.p.a. comply with applicable regulatory requirements and supporting timely, compliant commercialization.
With a focus on the Electrophysiology and Neurovascular businesses, the position applies in-depth regulatory knowledge to provide guidance to the Marketing organisation and cross-functional partners, interprets new and changing requirements, and coordinates actions to maintain compliance and market continuity.
Responsibilities: Act as the primary Regulatory Affairs partner for the Tender team, ensuring tender compliance and supporting preparation, review, and maintenance of regulatory documentation for public tenders and private offers.
Coordinate product registrations and notifications in line with Italian regulatory requirements, including submissions and maintenance of Ministry of Health databases and national registries, ensuring data accuracy and compliance throughout the product lifecycle.
Perform regulatory assessments and coordinate approvals for registrations, renewals, amendments, and market access activities, serving as liaison with local authorities and internal stakeholders.
Provide regulatory review and guidance for promotional and non-promotional materials, ensuring compliance with applicable regulations, industry codes, and Johnson & Johnson policies.
Collaborate with Marketing, Customer Care, Medical Affairs, Quality, Supply Chain, and other functions to integrate regulatory requirements into business and customer-facing activities.
Monitor and interpret new and changing Italian regulatory requirements, assess business impact, and support implementation of necessary actions.
Represent Regulatory Affairs in interactions with industry associations, trade organizations, and Italian Competent Authorities, as assigned.
Maintain regulatory documentation, records, and databases in an inspection-ready state and in compliance with quality and document management requirements.
Support regulatory strategy for product launches, lifecycle management, and market access initiatives in Italy.
Support internal and external audits, inspections, and compliance assessments, ensuring timely and accurate responses to regulatory inquiries.
Drive continuous improvement and simplification of regulatory processes to support operational excellence.
Manage regulatory projects and priorities independently, escalating complex or high-impact issues when appropriate.
Provide regulatory expertise on Italian requirements, registrations, and tender compliance, supporting internal stakeholders and developing junior colleagues.
Represent Regulatory Affairs on cross-functional projects, contribute to compliant policies and operational plans, and coach junior team members on regulatory processes and practices.
Requirements: University Bachelor degree or equivalent
In-depth working knowledge of EU medical device regulatory requirements and the ability to interpret and apply Italian requirements to assigned activities
2-4 years' experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries
Attitude to comprehend the Regulatory environment and understand the impact on the Company Business
Strong collaboration skills and ability to build partnerships internally and externally
Ability to work effective