Cardinal Health · 2 weeks ago
Principal Regulatory Affairs Specialist
United States
Full-time
Remote
Senior Level, Lead/Staff
$91K/yr - $110K/yr
5+ years expCardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices, leading new product development projects and ensuring compliance with global regulations.
Health CareHospitalMedical
Responsibilities
The Principal Regulatory Affairs Specialist is responsible for the support of new product development and maintenance of business projects. Specific activities include but are not limited to:
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
Qualification
Required
Bachelor's Degree in a scientific discipline or equivalent work experience
5-7 years Regulatory Affairs Experience
Majority of Regulatory Affairs experience in Medical Device industry
Strong organizational skills
Ability to manage multiple projects
Deadline conscious
Problem solving skills
Team oriented
Strong oral and written communication skills
Preferred
Proficiency in US and Europe medical device regulations
Experience in leading new and modified product development projects
Experience in preparing, submitting, and maintaining global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs
You may be expected to travel up to 10% of the time
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
Company
Cardinal Health
Cardinal Health is a manufacturer and distributor of medical and laboratory products.
10001+ employees
H1B Sponsorship
Cardinal Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (128)
2024 (116)
2023 (140)
2022 (158)
2021 (106)
2020 (142)
Funding
Current Stage
Public CompanyTotal Funding
$1.08B2025-08-28Post Ipo Debt· $1B
2006-08-16Post Ipo Debt· $78M
1983-08-12IPO
Leadership Team
Aaron Alt
Chief Financial Officer
T
Tony Caprio
Executive Vice President
Recent News
Morningstar.com
2026-01-16
Company data provided by crunchbase