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Associate Director, Regulatory Affairs
Johnson & JohnsonAssociate Director of Regulatory Affairs at Johnson & Johnson ensuring compliance for medical device registration. Leading regulatory strategy and team management across the MSM region.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs within the Medical Device industry, ensuring compliance with European and FDA regulations while leading teams and driving strategic initiatives for market access and business growth.
Highest-signal resume keywords
Regulatory Affairs LeadershipEU Medical Device RegulationsRegulatory Submissions ManagementStakeholder ManagementTeam Leadership and Development
ATS Keywords
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Hard Skills
Regulatory ComplianceMedical Device RegulationsRegulatory Policy ShapingRisk AssessmentAudit and Inspection ReadinessLifecycle ManagementMarket Access StrategiesRegulatory Risk MitigationTenders and Reimbursement SupportRegulatory Outreach Initiatives
Soft Skills
Excellent CommunicationOrganizational SkillsAttention to DetailCollaborationCoaching and Development
Industry Keywords
Medical Device IndustryHealthcare RegulationsCompetent AuthoritiesRegulatory AgenciesTrade Associations
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, support regulatory policy shaping activities, and partner closely with business stakeholders to ensure ongoing regulatory compliance and successful execution of business objectives.
- 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.
- Provide regulatory support for tenders, reimbursement activities, distributors, commercial operations, and franchise teams.
- 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.
- 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.
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.
Benefits
Comp & perks- Professional development opportunities
- Health insurance
- Flexible working hours
- Paid time off
- Inclusive work environment