Senior Legal Counsel, Regulatory Investigations (Northfield, IL)

Medline Industries, LP•Northfield, IL

3d•$177,000 - $266,000•Onsite

About The Position

Medline is seeking a Regulatory Investigations Attorney to lead internal investigations, regulatory inquiries, and enforcement-related matters. This role will serve as a central integrator across Legal, Quality, and Regulatory, ensuring timely, defensible, and well-structured responses to government and internal issues. The Attorney will not only manage investigations, but also design and implement scalable processes, escalation triggers, and governance mechanisms to strengthen Medline’s ability to detect, assess, and respond to regulatory risk.

Requirements

Juris Doctor degree
Member of a state bar in good standing
5 or more years of post-law school experience in regulatory, investigations, compliance, or FDA-related matters (law firm, in-house, or with the government)
Strong judgment in high-risk, ambiguous situations
Experience leading internal investigations or regulatory responses
Ability to synthesize complex factual records into clear legal positions
Excellent cross-functional communication and influence skills
Demonstrated ability to manage multiple high-priority matters simultaneously

Nice To Haves

Experience with healthcare, life sciences, or FDA-regulated environments
Familiarity with product quality systems, complaint handling, or recall processes
Experience building processes, playbooks, or governance frameworks
Comfort working in lean, fast-paced environments with high responsibility

Responsibilities

Lead Regulatory Investigations End-to-End
Direct internal investigations involving regulatory, quality, safety, and compliance issues
Assess facts, legal risk, and regulatory exposure; develop investigation strategy
Advise on remediation, disclosure decisions, and corrective actions
Interface with external counsel where appropriate
Integrate Legal–Quality–Regulatory Decision-Making
Act as embedded legal partner to Quality and Regulatory teams
Align stakeholders on risk framing, decision pathways, and timing
Identify when matters require escalation to senior leadership
Build Investigation and Escalation Frameworks
Develop and implement investigation protocols and playbooks and escalation triggers and decision thresholds
Drive Proactive Risk Identification and Mitigation
Identify patterns, root causes, and systemic risks across investigations
Partner with stakeholders to implement preventive measures
Support development of compliance and quality programs