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
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
May contribute 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
Anticipated salary range: $80,900 - $127,050
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
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 window anticipated to close: 06/21/2026 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
#LI-Hybrid
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Benefits
Health insuranceDental insuranceVision insurance401(k)Flexible scheduleEquity / stock optionsPerformance bonusParental leave
Additional Information
What Regulatory Affairs contributes to Cardinal Health
Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.
Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.
Location: The ideal candidate will reside within a reasonable commuting distance of one of our office locations: Waukegan, IL or El Paso, TX
Schedule: Hybrid. 1-2x a week in office.
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.
Cardinalhealth · Waukegan-mwdc, IL