Senior Regulatory Affairs Lead, MedTech EU

Johnson & Johnson MedTech; Madrid; On-site; EUR 55,000 - 88,000; Full time

Job summary

Johnson & Johnson MedTech in Madrid seeks a Senior Regulatory Affairs professional to lead planning, coordination and delivery of regulatory activities for EU markets. You will ensure compliance with EU MDR and local laws, interact with authorities, and support product launches across Electrophysiology and Neurovascular lines.

The role requires 4–6 years in Regulatory Affairs, strong cross-functional collaboration, and fluency in Spanish and English.

Qualifications

• 4–6 years’ experience in Regulatory Affairs or related discipline in medical devices or pharmaceutical industries.
• Good knowledge of EU medical device regulatory requirements.
• Excellent written and oral communication in Spanish and English.
• Strong collaboration skills in a highly matrixed organization.

Responsibilities

• Ensure compliance with EU and local legislation and regulatory authority requirements.
• Act as a contact for local Competent Authorities and coordinate responses when needed.
• Coordinate regulatory submissions and documentation for product lifecycle.
• Provide regulatory guidance for labeling, IFU, and promotional materials.
• Collaborate with Tender and Marketing partners to support business needs.

Skills

Regulatory affairs

EU medical devices

Regulatory compliance

Education

University degree in healthcare (pharmacy or medicine)

Job description

Johnson & Johnson MedTech in Madrid seeks a Senior Regulatory Affairs professional to lead planning, coordination and delivery of regulatory activities for EU markets. You will ensure compliance with EU MDR and local laws, interact with authorities, and support product launches across Electrophysiology and Neurovascular lines.

The role requires 4–6 years in Regulatory Affairs, strong cross-functional collaboration, and fluency in Spanish and English.