Director, Enterprise Regulatory Compliance

Key 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 device businesses.
• Provide independent assessments of manufacturing, quality, and compliance risks; ensure consistent application of global regulations and company standards across segments and sites.
• Review and classify Health Authority inspections and corporate cGMP audits for consistency.
• Review/initiate issue management for inspections and recalls following escalation policies and standards.
• 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 to requirements.
• Analyze regulatory compliance data and lead periodic data-driven compliance reviews for senior executives.
• Build AI literacy and use approved AI tools to improve analysis, synthesis, documentation, and quality checks (aligned with governance/privacy/responsible AI).
• Lead oversight/governance for significant compliance escalations and coordinate required actions/communications.
• Support audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned to enterprise objectives.
• Provide consultative expertise on compliance issue management and health authority responses/field action decisions.
• Deliver cGMP training on risk-based auditing strategies.

• Bachelor’s degree required; advanced degree/certification preferred.
• 10+ years relevant quality and compliance experience required.
• Prior cGMP regulatory compliance experience in medical device and/or pharma required.
• Health Authority/Notified Body experience preferred.
• Strong written/oral communication; leadership track record in cGMP compliance; ability to influence cross-culturally and across all org levels; thrive in complex matrix.
• Up to 20% domestic/international travel.

• Advanced Analytics
• Audit and compliance trends
• compliance management/risk
• confidentiality
• controls compliance
• internal auditing
• investigation techniques
• policy development
• report writing
• tactical planning
• technical credibility
• mentoring/developing others.

• Vacation (120 hrs/yr)
• Sick time (40 hrs/yr; CO:48; WA:56)
• Holiday incl. floating (13 days/yr)
• Work/Personal/Family Time (up to 40 hrs/yr)
• Parental Leave (480 hrs within one year)
• Bereavement (240 hrs immediate; 40 hrs extended)
• Caregiver Leave (80 hrs/52 weeks; incl. 10 days)
• Volunteer Leave (32 hrs/yr)
• Military Spouse Time-Off (80 hrs/yr).