Director, Regulatory Affairs

Johnson & Johnson

Director of Regulatory Affairs at Johnson & Johnson leading global regulatory strategy and product lifecycle management. Collaborating with cross-functional teams to assure timely commercialization of medical devices.

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 regulatory strategy formulation and execution for medical devices and biologics, with a strong focus on compliance and product lifecycle management. Proven ability to lead and develop teams while influencing stakeholders and driving innovative regulatory solutions.

Highest-signal resume keywords

Regulatory Strategy DevelopmentMedical Device ExperienceBiologics KnowledgeSenior Leadership ExperienceCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsProduct Lifecycle ManagementGlobal Regulatory ComplianceStrategic PlanningRisk Assessment

Soft Skills

LeadershipStrategic ThinkingInfluencing StakeholdersCommunicationMotivational Skills

Industry Keywords

Medical DevicesBiologicsClass 3 Implantable DevicesRegulated Industry ExperienceTrade Associations

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; manages, oversees and balances resource allocation across critical projects; and is responsible for regulatory aspects of product lifecycle management.
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 on the company's research and development programs to management.
Establish and ensure deployment of learning initiatives and training of cross functional partners on current and emerging regulatory and related requirements.
Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies.
Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements.
Assure timely regulatory clearances for key product launches in all key markets and assesses the current state of the department (organizational structure, competencies and skills) and implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives.
Inspire, motivate and communicate vision to regulatory associates, peers.
Identify and assess external innovation opportunities connected to the area of responsibility– both screening & technical due diligence (or designate team member).
Represent Johnson & Johnson’s strategic focus area in various internal and external forums and strategy/interactions.
Strategic thinking and ability to partner and Influence key stakeholders at senior levels.
Leverage expert scientific and technical understanding of medical devices and/or biologics to serve as an expert resource and strategic partner for development and planning throughout the product lifecycle in applicable markets (for example, partnering with business partners to proactively address safety issues).
Build, sustain, and reward a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
Leverage expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative results.
Advise and challenge others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo.
Makes and stands behind complex and difficult decisions in ambiguous situations with a large potential impact on the organization.

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.

Benefits

Comp & perks

Health insurance
401(k) matching
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
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year