Senior Legal Counsel, FDA Regulatory

Job Summary

Medline is seeking a Senior Legal Counsel to provide counsel to Medline’s business and functional leaders regarding applicable requirements of US Food and Drug Administration (FDA) regulations and related regulatory requirements. Reporting to the VP, Deputy General Counsel and Corporate Secretary, this attorney will be responsible for oversight of all legal aspects of the Company’s FDA compliance and will provide support of other matters related to healthcare regulatory requirements, collaborating closely within the Legal team and cross-functionally with the Company’s Quality, Compliance, and business teams.

Job Description

Key Responsibilities

Advise and assist the cross-functional business partners and senior management on a range of healthcare regulatory matters, including :

• Advise on FDA regulatory matters, including product approvals (e.g. 510(k)), labeling, advertising, marketing, complaint handling, recalls, field actions, promotional reviews, and other post-market compliance.
• Advise on FDA-related legal issues in product development, manufacturing, distribution, FDA enforcement actions, imports, and promotion of pharmaceutical, medical device, and biotechnology products.
• Support and, as appropriate, participate in or lead interactions with the FDA, including responding to FDA inquiries or inspections, submitting regulatory filings, and participating in meetings or negotiations.
• Support control gap assessment and remediation relating to FDA compliance
• Assist with due diligence for transactions, mergers, and securities offerings involving FDA-regulated entities.
• Help develop and implement regulatory strategies to support the Company’s business objectives while ensuring legal compliance.
• Provide guidance on global regulatory issues in coordination with international legal and regulatory teams.
• Support management of healthcare-related litigation and compliance issues as they arise.
• Support the conduct of internal audits and investigations to assess adherence to regulatory requirements.
• Identify and evaluate legal and business risks and opportunities for a healthcare company.
• Draft and review complex legal documents, including regulatory filings, policies, and compliance protocols.
• Conduct legal research and analysis on FDA and related regulations, policies, and industry trends Build and maintain strong relationships by providing sound legal advice on FDA-related matters.
• Manage outside counsel engaged to support complex or specialized matters.

Minimum Requirements

Relevant Work Experience

Education and Licensure

Skills and 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 :

$175,760.00 - $263,640.00 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 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.