Director, Regulatory Affairs

Johnson & Johnson

. Set regulatory strategy for product innovation, launch, and portfolio management .

Posted 10/23/2026full-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. Possesses strong leadership skills to manage regulatory affairs operations and influence senior stakeholders effectively.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentRegulatory Submissions ManagementMedical Device ExpertiseSenior Leadership ExperienceRegulatory Compliance Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submissions510(k)IDE/IDE SupplementsPMA/PMA SupplementsHDE/HDE SupplementsAnnual ReportsDesign DossiersChange NotificationsTechnical FilesRegulatory Strategy Execution

Soft Skills

Strategic ThinkingInfluencing StakeholdersTeam MobilizationCoaching and Educating

Certifications & Qualifications

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

Industry Keywords

Regulatory AffairsOrthopaedic ProductsClass III DevicesDigital Surgical RoboticsGlobal Regulatory RequirementsRegulated Industry Experience

About the role

Key responsibilities & impact

Set regulatory strategy for product innovation, launch, and portfolio management
Provide direction and leadership to Regulatory Affairs staff developing and implementing global regulatory strategies and processes
Lead and manage submissions and approvals with government regulatory agencies
Develop worldwide regulatory strategies for timely product approvals and continued support of marketed devices
Administer Regulatory Affairs operations and communicate business goals and objectives
Oversee preparation and maintenance of regulatory submissions and files for orthopaedic products, including Class III devices
Define strategic regulatory direction for pipeline development and global launch excellence
Partner with R&D, Quality, Supply Chain, Global Strategic Marketing, Policy, and other cross-functional leaders
Manage resource allocation across critical projects and regulatory aspects of product lifecycle management
Develop Regulatory staff and establish training initiatives for cross-functional partners
Monitor global regulatory changes and assess impacts on research and development programs
Coordinate communications with global, regional, and local regulatory agencies
Ensure company policies, procedures, and practices comply with regulatory requirements
Assure timely regulatory clearances for key product launches
Assess department capabilities and implement strategic and tactical plans
Represent Johnson & Johnson’s strategic focus area in internal and external forums
Cultivate relationships with regulators and influence regulatory changes
Mobilize and inspire teams to deliver on-time clearances
Educate and coach business partners on business plans and Regulatory Affairs strategies

Requirements

What you’ll need

Minimum of a Bachelors’ 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
Expert scientific and technical understanding of medical devices and/or biologics
Strategic thinking and ability to partner with and influence senior-level stakeholders
Experience with regulatory submissions including 510(k), IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files
Knowledge of global regulatory requirements and compliance

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
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 the 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
Inclusive interview process and disability accommodations