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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

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

- 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 Responsible is unavailable.
- Ensure that all medical devices comply with local legislation before being placed on the market, escalating material risks and recommending mitigation where required.




- Provide regulatory guidance for promotional and non-promotional materials through the local copy review process, ensuring compliance with applicable laws, regulations, industry codes, and internal Johnson & Johnson policies and procedures.
- Ensure that all promotional materials comply with EU regulations and applicable local legislation and requirements.
- Lead the local regulatory review of Instructions for Use, labelling information for marketed products, letters, notifications and promotional materials, when requested by the Manufacturer or Authorised Representative, ensuring accurate local-language translation and full compliance with local requirements.
- Serve as an RA partner to the Tender and Marketing departments, providing informed authoritative regulatory input on product technical characteristics and ensuring current documentation is available to support business and customer needs.
- Establish and maintain local Regulatory document database.
- Lead the planning, preparation and submission of detailed regulatory information required for submissions notifications and questions for new and existing products to meet applicable requirements and business timelines.
- Notify all class IIa, IIb and III medical devices in AEMPS database when they are made available on the Spanish market, resolving issues and ensuring completion within required timelines.
- Interpret existing, new and changing national regulatory requirements and provide clear, actionable guidance to J&J; businesses, independently evaluating impact.
- Supervise import activities to support the clearance process during health inspections at customs and independently authorise the release of imported lots after verifying compliance with local legislation, when

📌 Senior Regulatory Affairs Program Lead (Madrid)
🏢 Johnson & Johnson MedTech
📍 Madrid