Director, Enterprise Regulatory Compliance
Johnson & Johnson
September 03, 2026
Remote friendly (New Brunswick, NJ)
United States
Corporate Functions
Director, Enterprise Regulatory Compliance (Quality & Compliance)
Responsibilities:
- Serve as Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharma and medical devices.
- Provide independent assessments of manufacturing, quality, and compliance risks; support consistent application of global regulations, company standards, and policies.
- Review and classify Health Authority inspections and corporate cGMP audits for consistency.
- Review/initiate issue management for Health Authority inspections and recalls per escalation policies and standards.
- Support inspection readiness for Health Authority/Notified Body audits and pre-approvals.
- Review assigned US FDA response reviews for completeness, quality, and requirement alignment.
- Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.
- Build AI literacy and apply approved AI tools aligned to data governance, privacy, and responsible AI expectations.
- Lead governance for significant compliance escalations and support senior-leadership communications.
- Support audits, due diligence, and acquisition compliance assessments; influence outcomes in a matrixed organization.
- Provide consultative expertise on compliance issue management and health authority responses/field actions.
- Provide cGMP training to corporate and internal audit teams.
Qualifications:
- Bachelor’s degree minimum; advanced degree/certification preferred.
- 10+ years relevant quality and compliance experience required.
- cGMP regulatory compliance experience in medical devices and/or pharma required.
- Health Authority/Notified Body experience preferred.
- Strong written/oral communication; leadership track record; ability to influence across cultures/functions; work effectively in a complex matrix; up to 20% travel.
Preferred skills:
- Advanced analytics; audit/compliance trends; audit findings & recommendations; compliance management/risk; investigation techniques; policy development; report writing; tactical planning; internal auditing; mentorship; technical credibility.
Benefits (time off):
- Vacation 120 hrs/yr; sick time 40 hrs/yr (state-specific higher in CO/WA); holiday pay incl. 13 floating holidays/yr; work/personal/family time up to 40 hrs/yr; parental leave 480 hrs/yr; bereavement leave; caregiver leave; volunteer leave; military spouse time-off (hours as listed in posting).
Responsibilities:
- Serve as Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharma and medical devices.
- Provide independent assessments of manufacturing, quality, and compliance risks; support consistent application of global regulations, company standards, and policies.
- Review and classify Health Authority inspections and corporate cGMP audits for consistency.
- Review/initiate issue management for Health Authority inspections and recalls per escalation policies and standards.
- Support inspection readiness for Health Authority/Notified Body audits and pre-approvals.
- Review assigned US FDA response reviews for completeness, quality, and requirement alignment.
- Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.
- Build AI literacy and apply approved AI tools aligned to data governance, privacy, and responsible AI expectations.
- Lead governance for significant compliance escalations and support senior-leadership communications.
- Support audits, due diligence, and acquisition compliance assessments; influence outcomes in a matrixed organization.
- Provide consultative expertise on compliance issue management and health authority responses/field actions.
- Provide cGMP training to corporate and internal audit teams.
Qualifications:
- Bachelor’s degree minimum; advanced degree/certification preferred.
- 10+ years relevant quality and compliance experience required.
- cGMP regulatory compliance experience in medical devices and/or pharma required.
- Health Authority/Notified Body experience preferred.
- Strong written/oral communication; leadership track record; ability to influence across cultures/functions; work effectively in a complex matrix; up to 20% travel.
Preferred skills:
- Advanced analytics; audit/compliance trends; audit findings & recommendations; compliance management/risk; investigation techniques; policy development; report writing; tactical planning; internal auditing; mentorship; technical credibility.
Benefits (time off):
- Vacation 120 hrs/yr; sick time 40 hrs/yr (state-specific higher in CO/WA); holiday pay incl. 13 floating holidays/yr; work/personal/family time up to 40 hrs/yr; parental leave 480 hrs/yr; bereavement leave; caregiver leave; volunteer leave; military spouse time-off (hours as listed in posting).