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. 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: This is a remote position, and the ideal candidate will be located near or willing to travel to Waukegan, IL or Mansfield, MA.
Job Summary
The Principal Regulatory Affairs Specialist supports the Medical Solutions Regulatory Affairs team by managing regulatory requirements for international product registrations, developing global regulatory strategies, and supporting U.S. convenience kitting activities. The role leads regulatory efforts for new product development, manufacturing and product changes, regulatory submissions, compliance initiatives, and commercial support. This position works closely with cross-functional teams to ensure products meet U.S., EU, and international regulatory requirements while supporting business objectives and continuous process improvement.
Responsibilities
- Lead regulatory strategy for new and modified product development projects, ensuring regulatory requirements are integrated throughout the product lifecycle.
- Prepare, submit, and maintain global product registrations, including FDA 510(k) submissions, EU Technical Documentation, and International STEDs.
- Collaborate with global and regional regulatory teams to support international market access and ensure timely execution of regulatory strategies.
- Review product labeling to ensure compliance with global regulatory and medical device requirements.
- Monitor, interpret, and assess emerging medical device regulations, providing guidance on business impact and compliance requirements.
- Maintain regulatory intelligence, identify compliance risks, and develop mitigation and resolution strategies.
- Provide regulatory support for customer inquiries, bids and tenders, customs requests, OEM, Private Brand, Presource, and Sustainable Technologies businesses.
- Develop, implement, and maintain regulatory procedures, SOPs, and compliance processes.
- Manage regulatory data, analytics, and reporting through regulatory information management systems, including trend analysis of submission activities.
- Ensure global product and regulatory requirements are effectively implemented and maintained to support ongoing compliance and market access.
- Independently oversees multiple regulatory projects and develops regulatory strategies that optimize and accelerate market access opportunities. Successfully executes projects with limited support, proactively identifying emerging risks, regulatory challenges, and business impacts, while implementing solutions that ensure compliance and achievement of project goals.
Qualifications:
- Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred.
- 5+ years regulatory affairs experience preferred.
- Experience in medical device industry a plus.
- Proficiency in International STED, technical documents, and 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: 09/11/2026 *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.
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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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Skills Required
- Bachelor's degree in a scientific discipline or equivalent work experience
- 5+ years of regulatory affairs experience
- Experience in the medical device industry
- Proficiency with International STED, technical documents, and U.S. FDA medical device regulations
- 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
Cardinal Health Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cardinal Health and has not been reviewed or approved by Cardinal Health.
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Leave & Time Off Breadth — Paid time off is frequently described as generous, including examples like multiple weeks of vacation, additional sick days, and in some roles even “unlimited” or untracked time off. Parental leave, paid holidays, and volunteer time further broaden the overall leave offering.
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Healthcare Strength — Medical, dental, and vision coverage is positioned as comprehensive, with added supports such as preventive care, telehealth/clinic access, mental health resources, and EAP counseling. Wellness programs and incentives (e.g., premium discounts tied to checkups or healthy lifestyle actions) add to the perceived breadth of healthcare-related support.
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Retirement Support — A 401(k) with company match, along with programs like stock purchase/equity participation and charitable matching, contribute to a stronger total rewards picture beyond base pay. Additional financial supports such as disability coverage and early wage access also enhance the overall package.
Cardinal Health Insights
What We Do
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. We are navigating the complexities of healthcare and providing scaled solutions to help our customers thrive in a changing world. We strive to be a trusted healthcare partner by driving growth in evolving areas of healthcare, while building upon our distribution, products, and solutions to meet customer needs.
