Senior Regulatory Affairs Program Lead & Deputy Technical Responsible, Spain

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:
Madrid, Spain

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 Program Lead & Deputy Technical Responsible, leads the planning, coordination and delivery of regulatory affairs activities that ensure products distributed by Johnson & Johnson S.A.

(MedTech) comply with all applicable regulatory requirements and supports timely, compliant commercialisation.

With a focus on the Electrophysiology and Neurovascular businesses, the position provides experienced senior regulatory guidance to the Marketing Organisation and cross-functional partners, interprets new and changing requirements, and independently coordinates and leads appropriate actions to maintain compliance and market continuity.

The role maintains an effective relationship with the Competent Authority and, when the Technical Responsible is unavailable, independently assumes the responsibilities of Technical Responsible as defined in local medical device legislation (Royal Decree 192/2023 and the applicable provisions of Royal Decree 1591/2009) for J&J MedTech and Vision Care.

Essential duties and responsibilities:

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


* Ensure compliance with EU and local legislation, Regulatory Authority requirements and applicable standards, establishing compliant approaches and driving timely action across relevant functions.


* Act as a contact person for the local Competent Authorities for Medical Devices and independently coordinate clear, accurate and timely responses to regulatory agencies' questions, requests and other correspondence when the Technical R...