Sr Dir Regulatory Intelligence & FDA Engagement

Medline; United States; Remote; USD 203,000 - 305,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline is seeking a Senior Director for Regulatory Intelligence & FDA Engagement to lead a world-class regulatory intelligence capability. This role directs assessments of significant regulatory changes and drives implementation across the portfolio while serving as the enterprise authority on regulatory trends and enforcement actions.

The candidate will oversee governance, dashboards, and risk forecasting, coordinating with global teams to ensure scientifically sound and regulator-aligned

Qualifications

• Bachelor's degree in Regulatory Affairs or related field is required.
• 15+ years in Quality and/or Regulatory leadership roles preferred.
• Experience interacting with global health authorities (FDA, EMA, etc.).
• Experience leading enterprise-level remediation and regulatory responses.

Responsibilities

• Develop and execute global regulatory intelligence strategy.
• Lead responses to FDA enforcement actions and inspection findings.
• Coordinate cross-functional action plans and executive escalations.
• Oversee governance, policies, and metrics for regulatory intelligence activities.
• Prepare dashboards on regulatory changes, risks, and enforcement themes.
• Guide cross-functional teams through negotiations and remediation actions.

Skills

Regulatory leadership

FDA engagement

Regulatory intelligence

Strategic forecasting

Cross-functional leadership

Regulatory negotiations

FDA enforcement experience

Regulatory reporting

Education

Bachelor's in Regulatory Affairs or related field

Master's in Regulatory Affairs (preferred)

Job description

Sr Dir Regulatory Intelligence & FDA Engagement page is loaded## Sr Dir Regulatory Intelligence & FDA Engagementremote type: Remotelocations: Remote, UStime type: Full timeposted on: Posted Todayjob requisition id: R2621689**Job Summary**The Senior Director Regulatory Intelligence, FDA Engagement is responsible for establishing, leading, and continuously evolving a world-class regulatory intelligence capability that proactively identifies, assesses, communicates, and drives implementation of global regulatory requirements and emerging regulatory trends across the organization's portfolio. This leader serves as the enterprise authority for regulatory intelligence, providing strategic insight into evolving regulations, guidance documents, standards, enforcement actions, inspection trends, and policy developments that impact Medical Devices,**Job Description****MAJOR RESPONSIBILITIES:**Develop and execute the global regulatory intelligence strategy. Including:* Direct enterprise-wide impact assessments for significant regulatory changes.* Ensure appropriate prioritization based on 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+ Strategic opportunities* Serve as an enterprise expert in developing, reviewing, and approving regulatory response strategies.* Lead preparation of responses to:+ FDA+ Form 483 observations+ Untitled Letters+ Regulatory meeting commitments+ Requests for information+ Inspection follow-up correspondence+ Compliance and enforcement actions* Ensure responses are:+ Scientifically sound+ Strategically aligned+ Risk-based+ Defensible to regulators+ Supported by appropriate remediation plans+ Guide cross-functional teams through regulatory negotiations, commitments, and remediation activities.**MINIMUM JOB REQUIREMENTS:****Education:*** Bachelor's degree in Regulatory Affairs, biology, microbiology, biomedical engineering, pharmaceutical science, chemistry, life sciences, or related field.**Certification / Licensure:*** None**Work Experience:*** 10+ years of progressive Regulatory Affairs and/or Quality leadership experience* 8+ years interacting directly with global health authorities* Significant experience within highly regulated healthcare industries including:* Medical Devices* Pharmaceuticals/OTCs* Combination Products* Biologics* Human Tissue/HCT/P products* Nutritional Supplements**Knowledge / Skills / Abilities:*** Extensive demonstrated experience authoring, reviewing, and leading regulatory responses to FDA enforcement actions:* Direct authorship of numerous FDA Form 483 responses.* Development of remediation commitments and implementation plans.* Management of ongoing correspondence with FDA regarding compliance commitments.* Leadership of cross-functional teams supporting inspection response and remediation activities.* Experience negotiating regulatory commitments and demonstrating effectiveness of corrective actions.**PREFERRED JOB REQUIREMENTS:****Education:*** Master's degree in Regulatory Affairs, Project Management, or similar field, but not required.**Certification / Licensure:*** None**Work Experience:*** 15+ Years experience with 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* MFDS* Experience leading enterprise-level FDA remediation programs involving multiple facilities, product lines, and compliance workstreams.**Knowledge / Skills / Abilities:*** NoneMedline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.The anticipated salary range for this position:$203,000.00 - $305,000.00 AnnualThe actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click .We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page .Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.