Senior Regulatory Affairs Specialist

Cardinal Health

Regulatory Affairs Specialist providing regulatory expertise across diverse medical devices. Supporting product development, compliance activities, and integrating regulatory strategies into project workflows.

Posted 5/5/2026full-timeRemote • Illinois, Massachusetts • 🇺🇸 United StatesSenior💰 $66,500 - $88,020 per yearWebsite

About the role

Key responsibilities & impact

Support new and modified product development projects to establish and integrate regulatory strategy into project activities
Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs
Collaborate with internal Cardinal international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution
Review design control documents including documents associated with design inputs and design outputs
Review product labeling for compliance with global labeling regulations
Review advertising and promotional literature for compliance with applicable regulations
Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business
Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies
Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc.
Assist in the development, maintenance and implementation of regulatory procedures and SOPs

Requirements

What you’ll need

Bachelor’s degree or equivalent work experience preferred
2+ years Regulatory Affairs experience in the Medical Device industry preferred
Ability to manage multiple projects, while having strong organization skills, problem solving skills and being team oriented preferred
Strong interpersonal, verbal and written communication skills are preferred
Strong proficiency in Microsoft Office Applications preferred.

Benefits

Comp & perks

Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyglobal product registrations510(k)EU Technical DocumentsInternational STEDsdesign control documentsproduct labeling complianceadvertising complianceregulatory intelligenceregulatory procedures

Soft Skills

organization skillsproblem solving skillsteam orientedinterpersonal skillsverbal communication skillswritten communication skills