Associate Director, Regulatory Affairs, Electrophysiology

Johnson & Johnson

Associate Director leading regulatory affairs for medical devices at Johnson & Johnson. Focused on market access and regulatory compliance in the Electrophysiology division.

Posted 6/25/2026full-timeDiegem • 🇧🇪 BelgiumSeniorWebsite

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Hard Skills

Regulatory AffairsMedical Device RegulationsRegulatory SubmissionsLifecycle ManagementCompliance RequirementsAudit ReadinessProcess OptimizationStrategic Regulatory LeadershipRisk AssessmentStakeholder Management

Soft Skills

Team LeadershipCommunicationOrganizational SkillsAttention to DetailProblem-SolvingCritical ThinkingDecision-MakingResults-DrivenStrategic MindsetCollaboration

Certifications & Qualifications

Bachelor's Degree in Life SciencesBachelor's Degree in EngineeringBachelor's Degree in PharmacyBachelor's Degree in Regulatory Affairs

Industry Keywords

Healthcare ComplianceEuropean Regulatory RequirementsFDA RegulationsCompetent AuthoritiesHealth AuthoritiesMedical Device IndustryRegulatory AgenciesTrade AssociationsQuality ComplianceInternal Audits

About the role

Key responsibilities & impact

Ensure the timely registration and market access of medical devices across the MSM region in compliance with applicable European, FDA, national, and regional regulatory requirements.
Provide strategic regulatory leadership and partner closely with business stakeholders.
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.
Act as Regulatory Affairs Lead on cross-functional projects and regulatory initiatives.
Ensure compliance of the medical device portfolio with applicable regulatory requirements and company policies.
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.
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Inclusive work environment
Opportunities for professional development
Health insurance
Retirement plans