New · posted Oct 14
Cardinal Health · Medical Devices
Principal Regulatory Affairs Specialist
- Remote, US
- Remote
- Full-time
- Senior & Principal
Closes Oct 31, 2026 · 18 days left
The role
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.
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.
What you need
- 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 you'll do
- 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.
Pay and benefits
$80,900 – $127,050 a year
Employer providedWhat 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 *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.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Paid parental leave
Short- and long-term disability coverage
Working conditions
Location: This is a remote position, and the ideal candidate will be located near or willing to travel to Waukegan, IL or Mansfield, MA.
Equal opportunity, accessibility and legal noticesCardinal Health's statements, word for word
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.
To read and review this privacy notice click here
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 25% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Senior & Principal roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $80,900 | — | $127,050 |
| All US (middle half) | $117,000 | $139,500 | $150,000 |
This role: Cardinal Health's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 201 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Cardinal Health's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Regulatory submissions6
- Documentation and SOPs4
- Collaboration and leadership4
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Cardinal Health on Regulatory Jobs
- 37
- Open roles
- 31
- Distinct roles
- 18
- Locations
By discipline
- Quality32 86%
- Compliance & Safety3 8%
- Regulatory2 5%
By level
- Senior & Principal22 59%
- Manager6 16%
- Associate & Specialist6 16%
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Principal Regulatory Affairs Specialist at Cardinal Health
Applications close October 31. $81K–$127K a year, employer provided.