Director, Compliance

Johnson & Johnson

Director Compliance Principal responsible for regulatory compliance in MedTech at Johnson & Johnson. Leading compliance programs and ensuring adherence to global regulatory standards.

Posted 5/21/2026full-timeCincinnati • New Jersey, Ohio, Texas • 🇺🇸 United StatesLead💰 $150,000 - $258,750 per yearWebsite

About the role

Key responsibilities & impact

Responsible for supporting a robust regulatory compliance program for the worldwide headquarters, manufacturing sites, and R&D sites within the Surgery Segment of J&J MedTech
Understands the factors contributing to compliance risk profiles, based on metrics and data analysis and other intelligence (e.g., escalations, regulatory inspection outcomes, etc.), to proactively identify, communicate, prioritize, address/prevent/reduce compliance risk
Conducts Follow-up activities for the JJRC independent audit program, field action assessments, significant health authority inspections, post-acquisition assessments, and regulatory actions
Provides leadership and expertise to interpret and evaluate audit observations and provides guidance and support to develop risk-based action plans
Identifies opportunities for cross-regional/site remediation activities collaborate with Segment Quality and Compliance professionals to develop risk-minimizing strategies
Support supplier/EM compliance activities through the review of supplier audit reports and follow-up reports
Participates in early engagement activities with stakeholders
Assists with escalation and alignment activities associated with supplier/EM outcomes as needed
Provides oversight and compliance review of remediation programs (MCAP/SDCAP/QEP, PAM, etc.)
Ensures partnership with JJRC and other Q&C groups to leverage work / resources to minimize duplication
Interprets and communicates current and emerging regulatory and J&J requirements at a global level
Partners with Q&C and Enterprise Regulatory Outreach teams to continuously monitor the changing regulatory climate to proactively assess and communicate industry trends and emerging areas with potential impact to compliance programs
Serves as a key advisor and subject matter expert for critical compliance activities, including due diligence, mock inspections, regulatory agency interactions, decommissioning, divestiture, Compliance Data Reviews, special investigations, and business strategies, as needed
Supports Health Authority inspection readiness activities at high-risk sites, ensures subject matter expert preparedness, and reviews significant communications with Health Authorities
Engages with high risk sites, as needed, to oversee and, if necessary, verify remediation efforts.

Requirements

What you’ll need

5+ years of progressive experience in the medical device/biotech/pharmaceutical industry
Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment
Expert and broad-based knowledge of Quality System regulations, ISO, ICH, PIC/S, and GMP regulations
Experience performing GXP audits
Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, Notified Bodies, etc.
Ability to resolve complex regulatory compliance issues
Ability to analyze and interpret scientific and technical journals, and legal documents
Proven success in strategy development and project management, building consensus across broad geographies and business segments
Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood
Ability to effectively present information to executive management
Ability to drive successful program management and build strong cross-functional relationships
Ability to influence, negotiate, and build credibility to enable achievement of mutual goals
Strong skills in interdependent partnering to facilitate collaboration
Ability to perform work independently and proven experience in driving progress and remaining focused under ambiguous and complex situations.

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory compliancedata analysisaudit managementrisk assessmentGXP auditsQuality System regulationsISOGMP regulationsproject managementstrategy development

Soft Skills

leadershipcommunicationcollaborationinfluencenegotiationproblem-solvingindependent workadaptabilityconsensus buildingpresentation skills