What Quality & Regulatory Affairs contributes to Cardinal Health
Quality & Regulatory Affairs provides expertise and support to ensure products and operations comply with applicable regulatory requirements and quality standards. This function partners with internal and external stakeholders to maintain product registrations, support regulatory submissions, implement quality systems, and drive compliance activities throughout the product lifecycle.
Quality & Regulatory Affairs plans, coordinates, and implements regulatory and quality strategies for products that require government approval and ongoing compliance oversight. This job family proactively identifies regulatory and quality requirements and risks, supports product registrations and submissions, and contributes to the maintenance and continuous improvement of quality management systems.
Job Summary
The Sr. Specialist, Quality & Regulatory Affairs supports the implementation and maintenance of regulatory and quality compliance programs to ensure products and operations remain compliant with applicable regulations and company standards. The role supports regulatory submissions, product registrations, quality management system activities, audits, and compliance initiatives while collaborating with internal and external stakeholders to ensure safe and effective products are placed on the market.
Responsibilities
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Supports regulatory submissions, product registrations, license renewals, reimbursement activities, and regulatory database maintenance with applicable regulatory authorities and relevant agencies.
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Maintains regulatory documentation and supports compliance with local regulations, global requirements, company policies, and applicable quality system requirements.
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Assists in the implementation and maintenance of the Quality Management System (QMS), including document control, training management, change control, quality event management, and CAPA activities.
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Supports internal audits, external audits, regulatory inspections, and related compliance initiatives to ensure ongoing regulatory and quality compliance.
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Collaborates with cross-functional teams, including Commercial, Supply Chain, and Global Regulatory teams, and serves as a resource for regulatory and quality compliance matters by providing guidance and support to internal and external stakeholders.
Qualifications
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4+ years of experience in Regulatory Affairs, Quality Assurance, or a related medical devices industry function preferred.
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Bachelor's degree in Life Sciences, Engineering, or a related field, or equivalent work experience preferred.
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Knowledge of medical device regulatory requirements and quality systems preferred.
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Knowledge of MFDS regulations and quality system requirements is preferred.
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Strong communication, organizational, and stakeholder management skills.
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Experience supporting regulatory submissions, product registrations, audits, or quality management system activities is preferred.
What is expected of you and others at this level
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Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks.
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Works on projects of moderate scope and complexity.
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Identifies possible solutions to a variety of technical problems and takes action to resolve them.
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Apply judgment within defined parameters.
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Receives general guidance and may receive more detailed instruction on new assignments or projects.
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Work is reviewed for sound reasoning, quality, and accuracy.
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.
