Associate Director, Regulatory Affairs, MSM- Electrophysiology

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Job Function Regulatory Affairs Group

Job Sub Function Regulatory Affairs

Job Category People Leader

All Job Posting Locations: Diegem, Flemish Brabant, Belgium, Zuchwil, Switzerland

Job Description Position Overview

Johnson & Johnson MedTech 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.

Key Responsibilities

• 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 escalate 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.

Required Qualifications Education

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

Experience

• Minimum of 6 years of progressive Regulatory Affairs experience within the Medical D