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.
Regulatory 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.
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.
2+ years’ experience in Medical Device Regulatory Affairs/Quality experience preferred
Certification in regulatory affairs program preferred
Effective oral and written communication skills
Ability to create cross-functional partnerships
Ability to work collaboratively in a team environment
Applies basic concepts, principles, and technical capabilities to perform routine tasks
Works on projects of limited scope and complexity
Identifies possible solutions to a variety of technical problems and takes actions to resolve
Applies judgment within defined parameters
Receives general guidance may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy
Anticipated salary range: $76,7200 - $109,500
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Access to wages before pay day with myFlexPay
Application window anticipated to close: 7/25/2025 *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.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
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/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.
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Originally posted on Himalayas
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