Senior Regulatory Affairs Specialist

Medline Industries, LP

. planning and executing critical and complex global regulatory projects .

Posted 5/7/2026full-timeRemote • Illinois • 🇺🇸 United StatesSenior💰 $92,000 - $138,000 per yearWebsite

About the role

Key responsibilities & impact

planning and executing critical and complex global regulatory projects
Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes
Developing solutions to complex regulatory issues
Leading multifunctional teams in high-priority projects
Determine requirements for product submissions and regulatory filings
Monitor changes in regulations
Communicate requirements of regulations to customers
Recommend regulatory pathways, strategies, and solutions
Review and provide direction on supporting evidence
Complete and maintain varied regulatory filings
Participate in the development, review, and substantiation of product labeling and claims
Manage individual projects by providing direction on regulatory pathways
Assist in the review and development of processes related to regulatory activities
Participate in internal and external audits when applicable

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
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
Employee Assistance Program
Employee Resource Groups
Employee Service Corp

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesregulatory submissions510(k)CE Technical Filesregulatory filingsproduct labelingcompliance evaluationregulatory pathwaysregulatory issues resolutionaudit participation

Soft Skills

leadershipcommunicationteam managementproblem-solvingstrategic planningdirection providingcollaborationorganizational skillscustomer communicationproject management