Medline · 3 months ago
Senior Legal Counsel, FDA Regulatory
Northfield, Illinois
Full-time
Hybrid
Senior Level
$176K/yr - $264K/yr
5+ years expMedline Industries, LP is seeking a Senior Legal Counsel to provide counsel regarding FDA regulations and related regulatory requirements. This role involves oversight of the Company's FDA compliance and collaboration with various teams to ensure legal adherence in healthcare regulatory matters.
Consumer GoodsHealth CareHospitalityManufacturingMedical
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
Qualification
Required
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
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (344)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
Packaging-Gateway.com
2026-01-16
2026-01-13
Company data provided by crunchbase