Senior Legal Counsel, FDA Regulatory

Medline•Northfield, MN

About The Position

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.

Requirements

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

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.