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 / 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 responsibilities as per Quality Management SystemResponsabilidades
- 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 approvalsRequisitos 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