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

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...