Sr Dir Regulatory Intelligence & FDA Engagement

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 opportunitiesServe 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 actionsEnsure responses are: Scientifically sound Strategically aligned Risk-based Defensible to regulators Supported by appropriate remediation plansGuide cross-functional teams through regulatory negotiations, commitments, and remediation activities.

MINIMUM JOB REQUIREMENTS:

Education:

Certification / Licensure:

Work Experience:

Knowledge / Skills / Abilities:

PREFERRED JOB REQUIREMENTS:

Education:

Certification / Licensure:

Work Experience:

Knowledge / Skills / Abilities:

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.