Director, Enterprise Regulatory Compliance
Johnson & Johnson
September 03, 2026
Remote friendly (Raritan, NJ)
United States
Corporate Functions
Responsibilities:
- Serve as Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.
- Provide independent assessments of manufacturing, quality, and compliance risks to support consistent application of global regulations, company standards, and policies.
- Review and classify Health Authority inspections and corporate cGMP audits; review and initiate issue management for inspections and recalls.
- Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
- Review US FDA response reviews (as assigned) for completeness, quality, and alignment.
- Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.
- Build AI literacy and apply approved AI-enabled tools consistent with data governance, privacy, and responsible AI expectations.
- Lead governance for significant compliance escalations; align required actions and communications to senior leadership.
- Participate in corporate compliance audits, due diligence, and acquisition compliance assessments.
- Provide consultative expertise on compliance issue management and health authority responses/field actions.
- Provide cGMP training on risk-based auditing strategies.
Qualifications:
- Bachelor’s degree required; advanced degree or certification preferred.
- 10+ years relevant quality and compliance experience required.
- cGMP regulatory compliance experience in medical devices and/or pharmaceuticals required.
- Health Authority/Notified Body experience preferred.
- Strong written/oral communication; leadership track record; ability to influence across cultures/functions; thrive in a complex matrix; up to 20% travel.
Preferred skills:
- Advanced analytics; audit/compliance trends; compliance management and risk; confidentiality; internal auditing; investigation techniques; policy development; report writing; tactical planning; technical credibility.
Benefits (time off):
- Vacation: 120 hours/year; Sick time: 40 hours/year (CO 48; WA 56); Floating holidays/holiday pay: 13 days/year; Work/personal/family time: up to 40 hours/year; Parental leave: 480 hours; Bereavement leave: 240 hours immediate family (40 hours extended family); Caregiver leave: 80 hours (52-week rolling) / 10 days; Volunteer leave: 32 hours; Military spouse time-off: 80 hours/year.
- Serve as Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.
- Provide independent assessments of manufacturing, quality, and compliance risks to support consistent application of global regulations, company standards, and policies.
- Review and classify Health Authority inspections and corporate cGMP audits; review and initiate issue management for inspections and recalls.
- Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
- Review US FDA response reviews (as assigned) for completeness, quality, and alignment.
- Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.
- Build AI literacy and apply approved AI-enabled tools consistent with data governance, privacy, and responsible AI expectations.
- Lead governance for significant compliance escalations; align required actions and communications to senior leadership.
- Participate in corporate compliance audits, due diligence, and acquisition compliance assessments.
- Provide consultative expertise on compliance issue management and health authority responses/field actions.
- Provide cGMP training on risk-based auditing strategies.
Qualifications:
- Bachelor’s degree required; advanced degree or certification preferred.
- 10+ years relevant quality and compliance experience required.
- cGMP regulatory compliance experience in medical devices and/or pharmaceuticals required.
- Health Authority/Notified Body experience preferred.
- Strong written/oral communication; leadership track record; ability to influence across cultures/functions; thrive in a complex matrix; up to 20% travel.
Preferred skills:
- Advanced analytics; audit/compliance trends; compliance management and risk; confidentiality; internal auditing; investigation techniques; policy development; report writing; tactical planning; technical credibility.
Benefits (time off):
- Vacation: 120 hours/year; Sick time: 40 hours/year (CO 48; WA 56); Floating holidays/holiday pay: 13 days/year; Work/personal/family time: up to 40 hours/year; Parental leave: 480 hours; Bereavement leave: 240 hours immediate family (40 hours extended family); Caregiver leave: 80 hours (52-week rolling) / 10 days; Volunteer leave: 32 hours; Military spouse time-off: 80 hours/year.