Regulatory Affairs Lead, Medical Devices (Electrophysiology)

Johnson & Johnson Co.; Diegem; On-site; EUR 90,000 - 120,000; Full time

Job summary

Jobtailor seeks an experienced Regulatory Affairs Lead to register and gain market access for medical devices across the MSM region, ensuring compliance with European, FDA, national, and regional regulations. You will lead regulatory activities, collaborate with stakeholders, manage submissions, and drive process improvements, audits readiness and relationships with authorities.

Fluent English required; minimum 6 years in medical device regulatory affairs; strong leadership and strategic

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or related discipline.
• Minimum of 6 years regulatory affairs experience in medical devices or regulated healthcare.
• Experience interpreting local, regional and EU medical device regulations.
• People management experience with team leadership and development.
• Experience supporting regulatory submissions, registrations and lifecycle management.
• Strong knowledge of EU Medical Device Regulations and compliance requirements.
• Ability to translate regulatory requirements into actionable business guidance.
• Established relationships with Competent Authorities and industry associations.
• Excellent communication and stakeholder management skills.
• Strong organizational skills with attention to detail.
• Strategic mindset balancing short- and long-term objectives.
• Strong problem-solving and decision-making capabilities.
• Results-driven with urgency and accountability.
• Fluent English, both written and spoken.

Responsibilities

• Ensure timely registration and market access of medical devices across the MSM region.
• Provide strategic regulatory leadership and partner with business stakeholders.
• Lead regulatory activities to support growth and market access objectives.
• Drive regulatory shaping and outreach with Health Authorities and industry bodies.
• Assess impact of regulatory changes on products, registrations, licenses, and operations.
• Act as Regulatory Affairs Lead on cross-functional projects.
• Ensure portfolio compliance with regulatory requirements and company policies.
• Lead continuous improvement of regulatory processes and operations.
• Ensure audit readiness and represent during inspections.
• Communicate regulatory updates, risks, and recommendations to leadership.
• Oversee copy review and compliant communications.
• Lead, coach, and develop direct reports; foster high performance.
• Identify opportunities for process optimization and cost efficiencies.
• Ensure compliance with quality, legal, ethical, and HCC requirements.

Skills

Regulatory leadership

Stakeholder management

Team leadership

Strategic thinking

Regulatory submissions

Fluent English

Problem solving

Attention to detail

Education

Bachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or related discipline

Job description

Jobtailor seeks an experienced Regulatory Affairs Lead to register and gain market access for medical devices across the MSM region, ensuring compliance with European, FDA, national, and regional regulations. You will lead regulatory activities, collaborate with stakeholders, manage submissions, and drive process improvements, audits readiness and relationships with authorities.

Fluent English required; minimum 6 years in medical device regulatory affairs; strong leadership and strategic