Experteer Overview As a Senior Regulatory Affairs Leader for Med

Tech, 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 pharmaceuticals• Demonstrable knowledge of EU medical device regulatory requirements, compliance, and quality systems• Proven ability to work in a highly matrixed organization and build internal/external partnerships• Strong results orientation, urgency, and effective written/spoken communication in Spanish and English• University Degree in healthcare area (pharmacy or medicine)• Experience with regulatory submissions, importation, and market approvals

Requisitos principales• annual bonus with target• vacation days• parental leave• bereavement leave• caregiver leave• well-being reimbursement

📌 Senior Regulatory Affairs Program Lead & Deputy Technical Responsible, Spain (Madrid)
🏢 Johnson u0026 Johnson
📍 Madrid