Specialist, Quality & Regulatory Affairs (Fixed-Term Contract, 18 Months)

Job description

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 activities for products that require government approval and ongoing compliance oversight. This job family 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 Specialist, Quality & Regulatory Affairs supports the implementation and maintenance of regulatory and quality compliance programs to help ensure products and operations remain compliant with applicable regulations and company standards. Working under general guidance, the role supports regulatory submissions, product registrations, quality management system activities, audits, and compliance initiatives, while collaborating with internal and external stakeholders to help ensure safe and effective products are placed and maintained on the market. Responsibilities Supports regulatory submissions, product registrations, license renewals, reimbursement-related activities, and regulatory database maintenance with applicable regulatory authorities and relevant agencies. Prepares, maintains, and organizes regulatory documentation and records in accordance with local regulations, global requirements, company policies, and applicable quality system requirements. Assists with post-market regulatory activities, including product changes, labeling review, regulatory reporting, and license maintenance, as assigned. Assists in the implementation and maintenance of the Quality Management System (QMS), including document control, training management, change control, quality event management, complaint-related activities, and CAPA support. Supports audits, regulatory inspections, and follow-up activities to help ensure ongoing regulatory and quality compliance. Monitors assigned regulatory requirements and communicates relevant updates with guidance from senior QRA team members. Collaborates with cross-functional teams, including Commercial, Supply Chain, and Global Regulatory and Quality teams, to support regulatory and quality activities and respond to routine stakeholder requests. Manages assigned tasks and documentation accurately and within agreed timelines, escalating risks, delays, or issues when appropriate. Qualifications 1-3 years of relevant experience in Medical Device Regulatory Affairs, Quality Assurance, or Quality & Regulatory Affairs preferred. Bachelor's degree in Life Sciences, Engineering, or a related field, or equivalent work experience preferred. Basic working knowledge of medical device regulatory requirements and quality management systems preferred. Knowledge of Korean MFDS regulations and medical device quality system requirements is preferred. Experience supporting regulatory submissions, product registrations, license maintenance, audits, post-market activities, or QMS processes is preferred. Strong attention to detail and the ability to organize documentation and manage multiple assigned tasks. Effective written and verbal communication skills, with the ability to collaborate with local and global stakeholders. Business-level English communication skills are preferred. What is expected of you and others at this level Applies working knowledge of concepts, principles, and technical capabilities to perform assigned tasks. Works on projects and activities of limited to moderate scope and complexity. Identifies routine issues, gathers relevant information, and recommends or implements solutions within established procedures. Exercises judgment within defined parameters and escalates complex or higher-risk matters as appropriate. Works independently on routine assignments and receives guidance on new, complex, or non-routine tasks. Work is reviewed for sound reasoning, quality, accuracy, and compliance with applicable requirements. Builds job knowledge through practical experience, training, and collaboration with senior team members. 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 here