Senior Regulatory Affairs Specialist

Medline Industries, LP

Senior Regulatory Specialist responsible for planning and executing regulatory projects for medical devices at Medline. Ensuring compliance with FDA regulations and managing product submissions.

Posted 6/18/2026full-timeRemote • Illinois • 🇺🇸 United StatesSenior💰 $92,000 - $138,000 per yearWebsite

About the role

Key responsibilities & impact

Responsible for planning and executing global regulatory projects necessary to obtain and maintain global regulatory approvals
Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes
Identify factors that could impact the success or viability of new product launch in assigned market(s)
Monitor changes in regulations that impact current or future requirements and overall compliance
Communicate requirements of regulations to internal or external customers
Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements
Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups
Manage individual projects by providing direction on diverse regulatory pathways
Assist in the review and development of processes related to regulatory activities

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
At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets
Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files
Experience preparing responses and communicating with regulatory agencies
Understanding of the current Regulatory environment and ability to perform within
Applied knowledge of FDA regulations and guidelines
Ability to evaluate information to determine compliance with standards, laws, and regulations

Benefits

Comp & perks

health insurance
life and disability
401(k) contributions
paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesregulatory submissions510(k)CE Technical Filesregulatory filingscompliance evaluationFDA regulationsregulatory pathwaysproject managementdata analysis

Soft Skills

communicationcollaborationdirection providingproblem-solvingstrategic planningattention to detailorganizational skillsinterpersonal skillsadaptabilitycritical thinking