Principal Regulatory Affairs Specialist

Cardinal Health

Principal Regulatory Affairs Specialist leading regulatory strategy for 510(k) submissions in medical devices at Cardinal Health headquarters. Collaborating with international teams to ensure compliance and registrations globally.

Posted 6/10/2026full-timeWaukegan • Illinois, Texas • 🇺🇸 United StatesLead💰 $80,900 - $127,050 per yearWebsite

About the role

Key responsibilities & impact

Lead 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 Health 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.
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 submissions, customs queries, etc.
Development and implementation of regulatory procedures and SOPs.

Requirements

What you’ll need

Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred.
5-7 years regulatory affairs experience preferred.
Experience in medical device industry a plus.
Proficiency in US FDA medical devices regulations highly preferred.
Strong organizational and problem-solving skills.
Strong oral and written communication skills.
Ability to manage multiple projects while maintaining deadlines.
Ability to travel up to 10% of the time.

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 documentsregulatory proceduresSOPsUS FDA medical devices regulations

Soft Skills

organizational skillsproblem-solving skillsoral communication skillswritten communication skillsproject management

Certifications

Bachelor’s Degree in a scientific discipline