MedTech Regulatory Affairs Lead — EU Compliance & Strategy

Brighter Signals; Madrid; On-site; EUR 55,000 - 88,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Job summary

Johnson & Johnson Spain (MedTech) seeks a Senior Regulatory Affairs Program Lead & Deputy Technical Responsible to plan, coordinate and deliver regulatory activities ensuring compliance for devices distributed by J&J MedTech in Spain.

Focused on Electrophysiology and Neurovascular lines, the role provides senior regulatory guidance to Marketing and cross-functional partners, interprets new requirements, and leads actions to maintain market continuity.

Qualifications

• University degree in healthcare field (pharmacy or medicine).
• Demonstrable knowledge of medical device regulatory requirements, compliance, quality systems, importation or distribution activities and commercialization.
• 4–6 years’ experience in Regulatory Affairs or related discipline in medical device or pharmaceutical industries.
• Good knowledge of medical device regulatory requirements in the EU.
• Strong collaboration skills and ability to build partnerships.
• Ability to work effectively in a highly matrixed organization.
• Excellent written and oral communication skills in Spanish and English.

Responsibilities

• Lead planning, preparation and submission of regulatory information for new and existing products to meet requirements and timelines.
• Act as RA partner to Marketing and Tender departments, providing regulatory input on product characteristics.
• Coordinate regulatory responses to authorities when the Technical Responsible is unavailable.
• Liaise with Competent Authorities for Medical Devices and ensure compliance before market placement.

Skills

Regulatory Affairs

EU Medical Device Regulations

Audit & Compliance

Stakeholder Collaboration

Bilingual English/Spanish

Cross-functional teamwork

Education

Healthcare degree (pharmacy or medicine)

Regulatory Affairs degree

Job description

Johnson & Johnson Spain (MedTech) seeks a Senior Regulatory Affairs Program Lead & Deputy Technical Responsible to plan, coordinate and deliver regulatory activities ensuring compliance for devices distributed by J&J MedTech in Spain.

Focused on Electrophysiology and Neurovascular lines, the role provides senior regulatory guidance to Marketing and cross-functional partners, interprets new requirements, and leads actions to maintain market continuity.