Senior Legal Counsel, FDA Regulatory

Job Summary

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

• At least 5 years of strong experience practicing FDA law, at a major law firm or public corporation.

Education and Licensure

• Juris Doctor degree from an accredited law school and top academic credentials.
• Licensed to practice in Illinois or licensed and in good standing with another state bar and able to become licensed in Illinois.

Skills and Abilities

• Excellent business and legal judgment with the ability to make decisions and give practical advice that demonstrates an understanding of overall business objectives and the balance of risks and rewards in complex situations.
• Excellent communication and presentation skills, both verbal and written, including the ability to present complex topics in a concise and understandable manner and to collaborate with a range of partners.
• Ability to stay well-informed of emerging legal developments, market trends and practices, and risks related to public disclosures and corporate governance and eager to learn new areas of law.
• Strong interpersonal and organizational skills, attention to detail, and ability to thrive in a fast-paced environment.
• Proactive personality, committed to understanding the industry and the company’s business.

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:

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. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

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.