Senior regulatory affairs leader for Johnson & Johnson MedTech in Spain, overseeing compliance with EU and local medical device regulations for Electrophysiology and Neurovascular products. The role serves as deputy technical responsible and primary liaison with Spanish regulatory authorities, ensuring timely market access while maintaining regulatory compliance.
Responsibilities
- Ensure compliance with EU regulations and Spanish medical device legislation for marketed products
- Act as primary contact with Spanish Competent Authorities and coordinate regulatory submissions and responses
- Lead regulatory review of labelling, instructions for use, and promotional materials for local requirements
- Manage notifications of Class IIa, IIb, and III devices in AEMPS database and resolve related issues




- Supervise import clearance activities and authorise release of imported lots when Technical Responsible unavailable

Requirements
- University degree in pharmacy, medicine, or related healthcare field
- 4-6 years of medical device regulatory affairs experience
- Demonstrated knowledge of EU and Spanish medical device regulations and quality systems
- Experience with product importation, distribution, commercialisation, and compliance
- Proficiency in Spanish and English for regulatory communications
- Ability to independently manage regulatory authority correspondence and submissions

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