Principal Regulatory Affairs Specialist

Cardinal Health; United States; Remote; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Health savings account (HSA)

FSAs

Job summary

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to manage regulatory requirements for international product registrations, develop global regulatory strategies, and support U.S. convenience kitting activities.

You will lead regulatory efforts for new product development, manufacturing and product changes, and regulatory submissions, collaborating with cross-functional teams to ensure compliance with US, EU, and international requirements.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent work experience.
• 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 travel up to 10% of the time.

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.

Skills

Regulatory strategy

FDA submissions

Global regulatory

Regulatory intelligence

Cross-functional collaboration

Regulatory documentation

Project management

Education

Bachelor’s Degree in a scientific discipline

Tools

US FDA medical devices regulations

International STEDs

Job description

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: 10/31/2026

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 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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Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) 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. We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.

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