Director, Regulatory Affairs

Johnson & Johnson

Director of Regulatory Affairs managing global strategies for product compliance and launch. Leading regulatory teams at Johnson & Johnson for innovative orthopedic solutions.

Posted 7/18/2026full-timeRaynham • Massachusetts, Pennsylvania • 🇺🇸 United StatesLead💰 $164,000 - $282,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing global regulatory strategies for pipeline development and product launches, with a strong focus on compliance and leadership in the medical device and biologics sectors.

Highest-signal resume keywords

Regulatory Strategy DevelopmentMedical Device ExperienceBiologics/Biomaterials KnowledgeSenior Leadership ExperienceResource Allocation Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceGlobal Regulatory StrategyProject ManagementOperational ExecutionRegulatory Clearance Processes

Soft Skills

Independent JudgmentLeadership DevelopmentCollaborationCommunication

Industry Keywords

Regulated Industry ExperienceClass 3 Implantable DevicesDigital HealthTrade AssociationsPolicy Monitoring

About the role

Key responsibilities & impact

Define the strategic regulatory direction for pipeline development and global launch excellence.
Serve as member of TECA+S RA LT, TECA+S PLTs, including Sports/Soft Tissue, Trauma, CMFT, Bio and Spine (as needed) PLTs.
Partner with R&D and Global Strategic Marketing leaders as well as other functional leaders to develop and implement strategy for pipeline development and global launch excellence.
Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit.
Manage, oversee and balance resource allocation across critical projects.
Lead and develop Regulatory staff to become future leaders.
Partner with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations.
Ensure company policies, procedures and practices are in compliance with appropriate regulatory requirements.
Assure timely regulatory clearances for key product launches in all key markets.

Requirements

What you’ll need

A minimum of a bachelor’s degree is required.
An advanced degree is preferred.
Minimum 10 years relevant / regulated industry experience is required.
Previous experience with medical devices is required.
Previous experience with biologics/biomaterials, digital, Class 3 implantable devices is preferred.
Demonstrated track record of formulating global regulatory strategies that align with business deliverables is required.
Senior leadership experience is preferred, including line management of multiple levels of reporting.
Experience working with professional and trade associations is a plus.
May require up to 20% travel.

Benefits

Comp & perks

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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