Cardinal Health · 2 weeks ago
Sr. Regulatory Affairs Specialist
United States
Full-time
Remote
Mid, Senior Level
$77K/yr - $88K/yr
1+ years expCardinal Health is seeking a Senior Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices and will be responsible for various regulatory activities aligned with global medical device regulations.
Health CareHospitalMedical
Responsibilities
Under direction of manager, support new and modified product development projects to establish and integrate regulatory strategy into project activities
Lead, under direction of manager, 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 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
Review advertising and promotional literature for compliance with applicable regulations
Under direction of manager, 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 submission, customs queries, etc
Assists in the development, maintenance and implementation of regulatory procedures and SOPs
Qualification
Required
Ability to manage multiple projects, while having strong organization skills, problem solving skills and being team oriented
Strong interpersonal, verbal and written communication skills
Preferred
Bachelor's degree or equivalent work experience
1-3 years Regulatory Affairs experience, preferably in the Medical Device industry
Strong proficiency in Microsoft Office Applications
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