Sr Dir Regulatory Intelligence & FDA Engagement

Medline; United States; Remote; USD 203.000 - 305.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) contributions

Paid time off

Zusammenfassung

Medline is seeking a Senior Director Regulatory Intelligence, FDA Engagement, to establish and lead a world-class regulatory intelligence capability across Medical Devices, Pharmaceuticals, Cosmetics, and related products. You will partner with Regulatory Affairs, Quality, R&D, and Executive Leadership to translate regulatory changes into timely, risk-based business decisions.

Ideal candidates have extensive experience with FDA enforcement actions and a proven track record in remediation

Qualifikationen

• 10+ years of progressive Regulatory Affairs and/or Quality leadership experience.
• 8+ years interacting directly with global health authorities.
• Direct authorship of multiple FDA-483/Warning Letters and other responses to regulatory agencies.
• Experience negotiating regulatory commitments and remediation actions.

Aufgaben

• Develop and execute the global regulatory intelligence strategy.
• Lead preparation of responses to FDA observations and enforcement actions.
• Coordinate cross-functional action plans and executive escalations.
• Establish governance, policies, procedures, and metrics for regulatory intelligence activities.

Kenntnisse

Regulatory strategy

FDA engagement

Cross-functional leadership

Regulatory responses

Regulatory enforcement actions

Ausbildung

Bachelor’s degree in Regulatory Affairs

Master’s degree in Regulatory Affairs

Jobbeschreibung

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, Pharmaceuticals, Cosmetics, Human Tissue/HCT/P products, and Combination Products. The position partners closely with Regulatory Affairs, Quality, R&D, Medical Affairs, Supply Chain, Manufacturing, Legal, and Executive Leadership to ensure regulatory changes are translated into timely, risk-based business decisions and compliant implementation plans. Given the organization’s significant interaction with global health authorities, this role requires deep experience managing regulatory enforcement activities and developing successful responses to FDA observations, Warning Letters, and other regulatory actions.

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 FDA Warning Letters 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 Direct authorship of multiple FDA-483/Warning Letters and other responses to regulatory agencies Knowledge / Skills / Abilities: Extensive demonstrated experience authoring, reviewing, and leading regulatory responses to FDA enforcement actions: Direct authorship of multiple FDA Warning Letter responses. 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: None

Medline 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 Annual The 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 here.

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 here.

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.

Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.