Sr. Regulatory Affairs Specialist

What Regulatory Affairs contributes to Cardinal HealthRegulatory 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.ResponsibilitiesCollaborate 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 devicesSupports all pertinent activities to ensure global product and regulatory requirements are accounted for and implemented in a timely manner.QualificationsBachelors in related field, preferred2+ years’ experience in Medical Device Regulatory Affairs/Quality experience preferredCertification in regulatory affairs program preferredEffective project management skillsEffective oral and written communication skillsEffective problem-solving skillsAbility to create cross-functional partnershipsAbility to work collaboratively in a team environmentTravel Time required, up to 10%What is expected of you and others at this levelApplies basic concepts, principles, and technical capabilities to perform routine tasksWorks on projects of limited scope and complexityIdentifies possible solutions to a variety of technical problems and takes actions to resolveApplies judgment within defined parametersReceives general guidance may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracyAnticipated salary range: $76,7200 - $109,500Bonus eligible: NoBenefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication 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.To read and review this privacy notice click hereOriginally posted on Himalayas

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