Principal Regulatory Affairs Specialist

Job Summary

The Principal Regulatory Affairs Specialist will support the Medical Solutions Regulatory affairs team. They are responsible for regulatory activities associated with convenience kitting (Presource® kitting). This includes being regulatory lead for strategy, 510ks, and FDA regulations for the kitting products.

Responsibilities

• 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.

Qualifications

• 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.

What is expected of you and others at this level

Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
Contributes to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems
Solutions are innovative and consistent with organization objectives
Completes work; independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues

Pay

Anticipated salary range: $80,900 - $127,050

Benefits

• 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

Application

The application window anticipated to close: 06/21/2026