Senior MedTech Regulatory Affairs Lead (EU)

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

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Service awards

Insurance plans

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead & Deputy Technical Responsible for MedTech. Based in Madrid, you will lead regulatory activities for EU devices, ensuring compliance and timely market access. You will partner with marketing, QA, and operations to interpret regulatory changes and guide cross-functional teams.

You will oversee submissions, liaise with authorities, maintain regulatory documents, and mentor colleagues in regulatory techniques and responsibilities.

Qualifications

• University degree in healthcare (pharmacy or medicine).
• 4–6 years’ experience in Regulatory Affairs or related discipline in medical devices/pharma.
• Good knowledge of EU medical device regulatory requirements.
• Strong collaboration, communication, and ability to work in a matrixed organization.

Responsibilities

• Coordinate regulatory submissions and interactions for EU market needs.
• Act as RA contact with local Competent Authorities when needed.
• Lead regulatory planning, preparation, and submission activities for new/existing products.
• Maintain and manage local regulatory document databases and compliance processes.

Skills

Regulatory strategy

Cross-functional leadership

English proficiency

Spanish proficiency

Education

University degree in healthcare

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead & Deputy Technical Responsible for MedTech. Based in Madrid, you will lead regulatory activities for EU devices, ensuring compliance and timely market access. You will partner with marketing, QA, and operations to interpret regulatory changes and guide cross-functional teams.

You will oversee submissions, liaise with authorities, maintain regulatory documents, and mentor colleagues in regulatory techniques and responsibilities.