Director – Regulatory Affairs

Johnson & Johnson

. Set regulatory strategy and drive excellence in product innovation, launch and portfolio management .

Posted 10/8/2026full-timeUnited StatesLead💰 $164,000 - $282,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing global regulatory strategies for medical devices, ensuring compliance with regulatory requirements while leading cross-functional teams. Proven ability to manage product submissions and approvals, along with a strong background in regulatory affairs operations.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentRegulatory Submissions ManagementSenior Leadership ExperienceMedical Device ExpertiseRegulatory Compliance Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyProduct Submissions510(k) PreparationPMA SupplementsIDE/IDE SupplementsTechnical File MaintenanceRegulatory Affairs OperationsPortfolio ManagementRegulatory Environment MonitoringCross-Functional Collaboration

Soft Skills

LeadershipCommunicationTraining and DevelopmentResource AllocationStrategic Planning

Certifications & Qualifications

Bachelor's DegreeM.S.M.E.PhDMD

Industry Keywords

Medical DevicesDigital Surgical RoboticsRegulated Industry ExperienceRegulatory AgenciesProduct Lifecycle Management

About the role

Key responsibilities & impact

Set regulatory strategy and drive excellence in product innovation, launch and portfolio management
Provide direction and leadership to Regulatory staff developing and implementing global regulatory strategies and processes
Lead and manage product submissions and approvals with government regulatory agencies
Develop worldwide regulatory strategies for timely device approvals and continued regulatory support of marketed products
Administer Regulatory Affairs operations and communicate business goals and objectives
Oversee preparation and maintenance of 510(k), IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files
Define strategic regulatory direction for pipeline development and global launch excellence
Partner with R&D, Quality, Supply Chain, Global Strategic Marketing and other cross-functional leaders
Manage resource allocation across critical projects and regulatory aspects of product lifecycle management
Lead and develop Regulatory staff
Monitor the global regulatory environment and assess impacts of changing regulations
Establish learning initiatives and train cross-functional partners on regulatory requirements
Coordinate communications with global and regional/local regulatory agencies
Ensure company policies, procedures and practices comply with regulatory requirements
Assure timely regulatory clearances for key product launches
Assess departmental organizational structure, competencies and skills and implement strategic and tactical plans
Identify and assess external innovation opportunities, including screening and technical due diligence
Represent Johnson & Johnson’s strategic focus area in internal and external forums

Requirements

What you’ll need

Minimum of a Bachelor’s degree within a technical related discipline is required
Minimum 10 years relevant / regulated industry experience is required
Previous experience with medical devices and digital surgical robotics is strongly preferred
Senior leadership experience is required, including line management of multiple levels of reporting
Demonstrated track record of developing and executing global regulatory strategies aligned with business deliverables is required
M.S., M.E., PhD or MD is highly preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing in Washington
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year