Experteer Overview 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 / Incentivos • 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 responsibilities as per Quality Management System Responsabilidades • 4-6 years of Regulatory Affairs experience in medical devices or ph

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