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.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 https://www.jnj.com/medtec

Purpose: 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:

Under moderate supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, the essential duties and responsibilities of this position are:



* 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, ensur...