Associate Director, Regulatory Affairs, MSM- EP​/NV

Job Function

Regulatory Affairs Group

Regulatory Affairs

People Leader

Diegem, Flemish Brabant, Belgium, Zuchwil, Switzerland

Position Overview

Johnson & Johnson Med Tech is recruiting for an Associate Director, Regulatory Affairs, MSM – Electrophysiology (EP).

This role is responsible for ensuring the timely registration and market access of medical devices across the MSM region in compliance with applicable European, FDA, national, and regional regulatory requirements. The successful candidate will provide strategic regulatory leadership, support regulatory policy shaping activities, and partner closely with business stakeholders to ensure ongoing regulatory compliance and successful execution of business objectives.

The Associate Director will play a key role in regulatory strategy development, external regulatory engagement, regulatory compliance oversight, and leadership of a regional Regulatory Affairs team.

• Lead regulatory affairs activities across the MSM region to support business growth and market access objectives.
• Drive regulatory shaping and outreach initiatives through engagement with Health Authorities, regulatory agencies, and industry trade associations.
• Assess and communicate the impact of changing regulatory requirements on products, registrations, licenses, and business operations.
• Partner with global and regional Regulatory Affairs teams, commercial teams, distributors, and business partners to provide regulatory guidance and strategic support.
• Act as Regulatory Affairs Lead or representative on cross-functional projects and regulatory initiatives.
• Ensure compliance of the medical device portfolio with applicable regulatory requirements and company policies.
• Provide regulatory support for tenders, reimbursement activities, distributors, commercial operations, and franchise teams.
• Lead continuous improvement initiatives to strengthen regulatory processes and operational excellence.
• Ensure audit and inspection readiness and represent Regulatory Affairs during internal audits and Health Authority inspections.
• Communicate regulatory compliance updates, risks, and recommendations to leadership and key stakeholders.
• Oversee the Copy Review process and support compliant promotional and non-promotional communications.
• Identify, assess, and escalation regulatory risks while driving effective mitigation plans.
• Lead, coach, and develop direct reports while fostering a high-performing and collaborative team environment.
• Identify opportunities for process optimization and cost efficiencies.
• Ensure compliance with all applicable quality, legal, ethical, and Healthcare Compliance (HCC) requirements.

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

• Minimum of 6 years of progressive Regulatory Affairs experience within the Medical Device industry or other highly regulated healthcare environments.
• Demonstrated experience interpreting and applying local, regional, and European medical device regulations.
• Prior people management experience with responsibility for team leadership and development.
• Experience supporting regulatory submissions, registrations, and lifecycle management activities.

• Strong knowledge of EU Medical Device Regulations and regulatory compliance requirements.
• Ability to assess regulatory requirements and translate them into actionable business guidance.
• Established relationships or experience interacting with Competent Authorities and industry associations.
• Excellent communication and stakeholder management skills.
• Strong organizational skills with exceptional attention to detail.
• Strategic mindset with the ability to balance short-term priorities and long-term objectives.
• Strong problem-solving, critical thinking, and decision-making capabilities.
• Results-driven with a strong sense of urgency and accountability.
• Fluent English, both written and spoken.

• MBA, Master's degree, or other advanced scientific or business degree.
• Experience with in Electrophysiology,…