Experteer Overview

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As a Senior Regulatory Affairs Leader for MedTech, you will steer regulatory planning, coordination and delivery to ensure compliant product distribution in Spain. You will guide the Marketing Organisation and cross-functional partners, interpret evolving rules, and manage timely regulatory actions. You’ll act as a liaison with competent authorities and, when needed, assume Technical Responsible duties under local medical device laws. This role blends leadership in regulatory strategy with hands-on compliance work to enable market continuity and safe patient care.

Compensaciones / Ventajas
• Ensure EU and local regulatory compliance across functions and drive timely actions
• Serve as local authority contact for Medical Devices and coordinate responses when Technical Responsible is unavailable
• Ensure medical devices meet local legislation before market launch and escalate risks




• Provide regulatory review for promotional materials and ensure compliance with laws and policies
• Lead regulatory review of Instructions for Use, labeling, and translations for local markets
• Collaborate with Tender and Marketing to provide regulatory input on product characteristics
• Maintain local Regulatory document database
• Plan and submit regulatory information for new and existing products within timelines
• Notify class IIa/IIb/III devices to AEMPS and manage issues to meet deadlines
• Interpret regulatory changes and advise JJ businesses on impact
• Oversee import activities and release of imported lots when needed
• Coordinate regulatory fixes between MDRIM and RAD and drive timely closures
• Act as accountable RA partner for CIGNON approvals supporting new launches
• Maintain MDRIM system in line with end-to-end strategy
• Represent RA on cross-functional teams and coach colleagues on regulatory practices
• Additional r

📌 Senior Regulatory Affairs Program Lead (Madrid)
🏢 Johnson u0026 Johnson
📍 Madrid