Principal Regulatory Affairs

Medline Industries, LP

. Develop regulatory strategies for global approvals introducing new products to market and maintaining existing products .

Posted 10/9/2026full-timeRemote • Illinois • United StatesLead💰 $116,000 - $174,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing regulatory strategies for global product approvals in the medical device industry, with a strong focus on compliance, negotiation with regulatory authorities, and project management.

Highest-signal resume keywords

Regulatory Strategy DevelopmentRegulatory Submissions (510(k)s, CE Technical Files)Global Regulatory ComplianceNegotiation with Regulatory AgenciesProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory FilingsRisk ManagementRegulatory Intelligence ProgramsCompliance MonitoringTechnical Process ImprovementProduct Labeling and Claims DevelopmentEvidence Review for ComplianceIndependent Regulatory SubmissionsHarmonized Standards KnowledgeRegulatory Requirements Communication

Soft Skills

Independent WorkLeadershipCommunicationProblem SolvingTeam Coordination

Tools & Technologies

Compliance DatabasesRegulatory Management Software

Industry Keywords

Medical Device IndustryFDANotified BodiesPre-Market Regulatory ActivitiesPost-Market Regulatory Activities

About the role

Key responsibilities & impact

Develop regulatory strategies for global approvals introducing new products to market and maintaining existing products
Negotiate with regulatory authorities and inform future product development
Resolve regulatory issues independently and provide direction on large-scale projects
Determine requirements for product submissions and regulatory filings for clearance/approval in assigned markets
Identify and solve factors affecting new product launch success or viability
Monitor regulatory changes and execute necessary compliance changes
Acquire and apply harmonized standards knowledge
Communicate regulatory requirements to internal and external customers
Recommend regulatory pathways, strategies, solutions, and future actions
Review evidence for compliance with regulations, guidance documents, and standards
Lead regulatory filings and coordinate internal and external groups
Communicate with regulators regarding non-conformances and questions
Lead product labeling and claims development, review, and substantiation
Manage complex projects, timelines, technical deliverables, and multifaceted teams
Improve and develop regulatory-driven and technical processes
Maintain compliance databases, logs, and files
Lead audits and manage post-audit corrective actions

Requirements

What you’ll need

B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
5+ years of diverse regulatory experience in the medical device industry
Strong global regulatory background supporting pre- and post-market regulatory activities
Experience with independent regulatory submissions
Experience participating in regulatory intelligence programs
Experience developing and implementing regulatory strategies in multiple international markets
Ability to lead efforts related to risk management and design and development
Extensive experience authoring and submitting regulatory submissions, including 510(k)s and CE Technical Files
Extensive experience communicating and negotiating with regulatory agencies, including FDA and notified bodies
Ability to work independently and lead large-scale projects with significant business impact

Benefits

Comp & perks

Competitive total rewards package
Continuing education & training
Health insurance
Life and disability insurance
401(k) contributions
Paid time off
Employee Assistance Program
Employee Resource Groups
Employee Service Corp
Bonus and/or incentive eligibility
Career growth opportunities