Senior Regulatory Affairs Specialist

What Regulatory Affairs contributes to Cardinal Health At Cardinal Health, the Regulatory Affairs team plays a crucial role in providing the expertise necessary for pharmaceutical, medical, and biotechnology companies to achieve regulatory approvals. Our comprehensive services include technical writing, regulatory submissions, clinical research, and consulting for manufacturing processes. We proactively craft regulatory strategies for products that need government approval, identifying requirements and potential risks to devise effective plans for product development and submissions. Key Responsibilities Collaborate with Cardinal's regulatory partners on product development projects, ensuring the integration of international regulatory strategies for timely execution. Provide regulatory information to support customer inquiries, bid submissions, and customs queries. Offer regulatory support for various businesses, including OEM, Private Brand, Presource, and Sustainable Technologies across a range of medical devices. Maintain regulatory data and analytics through our information management systems, performing trend analysis for submissions and generating necessary reports. Assist with the preparation and maintenance of global product registrations with a focus on STEDs. Support the development and enhancement of regulatory procedures. Interpret and evaluate proposed regulations for medical devices under the guidance of management. Handle activities to ensure compliance with global product and regulatory requirements. Qualifications Bachelor's degree in a related field or equivalent work experience is preferred. 2+ years of experience in Medical Device Regulatory Affairs or Quality is preferred. Regulatory Affairs certification is a plus. Strong project management skills. Exceptional oral and written communication skills. Proficient problem-solving abilities. Able to foster cross-functional partnerships. Collaborative team player. Willing to travel up to 10%. Expectations at this Level Utilize basic concepts and principles to perform routine tasks. Work on projects of limited scope and complexity. Identify solutions to a variety of technical problems and take action to resolve them. Apply judgment within defined parameters. Receive general guidance with the possibility of detailed instructions for new projects. Work is reviewed for logical reasoning and accuracy. Salary Range: $68,500 - $88,020 Bonus Eligibility: No Benefits: Cardinal Health offers a comprehensive benefits package, including: Medical, dental, and vision coverage Paid time off Health savings account (HSA) 401(k) savings plan Access to early wages with myFlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-life resources Paid parental leave Healthy lifestyle programs Application Deadline: 2/18/2026. If interested in this opportunity, please submit your application as soon as possible. The listed salary range is an estimate. Compensation at Cardinal Health is determined by various factors, including geographical location, education, experience, and internal pay equity assessments. Candidates who are back-to-work, individuals with disabilities, those without a college degree, and veterans are encouraged to apply. Cardinal Health is committed to an inclusive workplace that values diverse thoughts, experiences, and backgrounds. We embrace our differences to create better solutions for our customers, allowing employees to be their authentic selves daily. Cardinal Health is an Equal Opportunity/Affirmative Action 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. For more information, please refer to our privacy notice.

Created: 2026-03-05