Sr. Regulatory Affairs Specialist jobs in United States
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Cardinal Health · 3 days ago

Sr. Regulatory Affairs Specialist

Cardinal Health provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. The Sr. Regulatory Affairs Specialist will collaborate with internal partners on product development projects, maintain regulatory data, and support global product registrations and regulatory procedures.

Health CareHospitalMedical
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H1B Sponsor Likelynote

Responsibilities

Collaborate with internal Cardinal regional regulatory partners on new and modified product development projects, to establish and integrate international regulatory strategy into project activities and ensure timely execution
Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc
Provide regulatory support to OEM, Private Brand, Presource, and Sustainable Technologies businesses and range of medical devices
Maintain regulatory data, intelligence, and analytics through use of CAH regulatory information management systems, including trend analysis of critical regulatory submission related activities, and generate needed reports
Support preparation / maintenance of global product registrations with focus on STEDs
Support development, maintenance and implementation of regulatory procedures
Under direction of manager, assist in interpreting and evaluating proposed regulations for medical devices
Supports all pertinent activities to ensure global product and regulatory requirements are accounted for and implemented in a timely manner

Qualification

Medical Device Regulatory AffairsRegulatory Affairs CertificationProject ManagementCross-Functional PartnershipsOral CommunicationWritten CommunicationProblem-SolvingTeam Collaboration

Required

Bachelors in related field or equivalent work experience
2+ years' experience in Medical Device Regulatory Affairs/Quality experience
Effective project management skills
Effective oral and written communication skills
Effective problem-solving skills
Ability to create cross-functional partnerships
Ability to work collaboratively in a team environment
Travel Time required, up to 10%

Preferred

Certification in regulatory affairs program

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

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Cardinal Health is a manufacturer and distributor of medical and laboratory products.

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 Company
Total Funding
$1.08B
2025-08-28Post Ipo Debt· $1B
2006-08-16Post Ipo Debt· $78M
1983-08-12IPO

Leadership Team

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Aaron Alt
Chief Financial Officer
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T
Tony Caprio
Executive Vice President
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Company data provided by crunchbase