Sr Dir Regulatory Intelligence & FDA Engagement
About The Position
The Senior Director Regulatory Intelligence, FDA Engagement establishes, leads, and continuously evolves a regulatory intelligence capability that identifies, assesses, communicates, and drives implementation of global regulatory requirements and emerging trends across the organization’s portfolio. The role serves as the enterprise authority for regulatory intelligence, providing strategic insight on regulations, guidance documents, standards, enforcement actions, inspection trends, and policy developments affecting medical devices, pharmaceuticals, cosmetics, human tissue/HCT/P products, and combination products. The position partners with Regulatory Affairs, Quality, R&D, Medical Affairs, Supply Chain, Manufacturing, Legal, and Executive Leadership to translate regulatory changes into timely, risk-based business decisions and compliant implementation plans. It also leads regulatory response strategies and cross-functional work involving FDA observations, Warning Letters, and other regulatory actions, including response preparation, remediation planning, regulatory negotiations, and commitments.
Requirements
- Bachelor’s degree in Regulatory Affairs, biology, microbiology, biomedical engineering, pharmaceutical science, chemistry, life sciences, or a related field.
- 10+ years of progressive Regulatory Affairs and/or Quality leadership experience.
- 8+ years interacting directly with global health authorities.
- Significant experience in highly regulated healthcare industries, including medical devices, pharmaceuticals/OTCs, combination products, biologics, human tissue/HCT/P products, or nutritional supplements.
- Direct authorship of multiple FDA Form 483 responses, FDA Warning Letter responses, and other responses to regulatory agencies.
- Extensive demonstrated experience authoring, reviewing, and leading regulatory responses to FDA enforcement actions.
- Experience developing remediation commitments and implementation plans.
- Experience managing ongoing correspondence with FDA regarding compliance commitments.
- Experience leading cross-functional teams supporting inspection response and remediation activities.
- Experience negotiating regulatory commitments and demonstrating the effectiveness of corrective actions.
Nice To Haves
- Master’s degree in Regulatory Affairs, Project Management, or a similar field.
- 15+ years of progressive experience in Quality and/or Regulatory leadership roles.
- Experience establishing or leading a Regulatory Intelligence function.
- Experience supporting enterprise-wide quality transformation or remediation programs.
- Experience operating across multiple major regulatory jurisdictions, including FDA, European Commission/EMA, Health Canada, PMDA, TGA, and MFDS.
- Experience leading enterprise-level FDA remediation programs involving multiple facilities, product lines, and compliance workstreams.
Responsibilities
- Develop and execute the global regulatory intelligence strategy.
- Direct enterprise-wide impact assessments for significant regulatory changes, prioritizing them according to business, compliance, product, and patient risk.
- Coordinate cross-functional action plans and executive escalations.
- Establish governance, policies, procedures, and metrics for regulatory intelligence activities that drive implementation of regulatory requirements.
- Build a centralized regulatory intelligence function supporting all product categories and global markets.
- Develop long-range regulatory risk assessments and strategic forecasting capabilities.
- Identify emerging regulatory trends and advise leadership on potential business impacts.
- Prepare dashboards summarizing regulatory changes, compliance risks, industry trends, emerging enforcement themes, and strategic opportunities.
- Serve as an enterprise expert in developing, reviewing, and approving regulatory response strategies.
- Lead preparation of responses to FDA Form 483 observations, FDA Warning Letters, Untitled Letters, regulatory meeting commitments, requests for information, inspection follow-up correspondence, and compliance and enforcement actions.
- Ensure regulatory responses are scientifically sound, strategically aligned, risk-based, defensible to regulators, and supported by appropriate remediation plans.
- Guide cross-functional teams through regulatory negotiations, commitments, and remediation activities.
Benefits
- Competitive total rewards package
- Continuing education and training
- Health insurance
- Life insurance
- Disability insurance
- 401(k) contributions
- Paid time off
- Employee Assistance Program (for employees working less than 30 hours per week)
- Employee Resource Groups (for employees working less than 30 hours per week)
- Employee Service Corp (for employees working less than 30 hours per week)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
