Apply Online for QRA Senior Specialist at Cardinal Health

Cardinal Health distributes pharmaceuticals, manufactures and distributes medical and laboratory products, and provides performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driven insights that advance healthcare and improve lives every day.

Post : Sr. Specialist, QRA

Job Summary
The Senior Specialist supports Regulatory Operations and advances global regulatory compliance through the management of regulatory processes, systems, data, and operational activities across the product lifecycle. This role serves as a key contributor to regulatory operations by ensuring the accuracy, integrity, and compliance of regulatory information used for global submissions, registrations, product maintenance, and post-market activities.

The Senior Regulatory Affairs Specialist applies a strong understanding of medical device or pharmaceutical regulations, Quality Management system and regulatory operations processes to maintain compliant regulatory databases, support global market registrations, facilitate regulatory reporting, and drive process improvements. Working collaboratively with Regulatory Affairs, Quality, R&D, Clinical, Manufacturing, Supply Chain, and IT, this individual contributes to the development of scalable and efficient regulatory operations capabilities that support business objectives and regulatory compliance.

Responsibilities
Regulatory Operations & Compliance
• Support the development, implementation, and continuous improvement of regulatory operations processes, procedures, systems, and tools.
• Ensure compliance with applicable global regulatory requirements, including FDA regulations, EU MDR, ISO 13485, and other international regulatory frameworks.
• Monitor changes in regulatory requirements and assess potential impacts on regulatory operations processes and systems.
• Regulatory Data Management- Maintain, review, and manage regulatory data within internal systems and regulatory databases.
• Conduct technical review, remediation, and verification of regulatory data to ensure completeness, accuracy, consistency, traceability, and compliance.
• Support regulatory submissions and registrations through data preparation and maintenance activities, including databases such as GUDID, EUDAMED, and other global regulatory systems.
Systems, Reporting & Analytics
• Support administration, enhancement, and effective utilization of regulatory information management systems and other digital tools supporting regulatory compliance.
• Develop and maintain reports, dashboards, and performance metrics utilizing tools such as Excel, Power BI, and similar reporting platforms.
• Analyze regulatory data to identify trends, compliance risks, and opportunities for process improvements.
• Partner with business stakeholders and IT teams to support system improvements, data migrations, and implementation of new technologies.

Quality & Audit Readiness
• Support internal and external audits, inspections, and compliance assessments by preparing documentation and providing evidence of regulatory compliance.
• Assist in risk assessments related to regulatory processes, systems, and data integrity.
• Maintain inspection readiness by ensuring regulatory records and documentation are complete, accurate, and retrievable.
Project & Cross-Functional Support
• Independently manage low to medium medium-complexity projects and assigned regulatory operational initiatives.
• Collaborate with cross-functional teams to resolve operational challenges and improve regulatory processes.
• Support regulatory labeling, Instructions for Use (IFUs), Declarations of Conformity (DoCs), website postings, and other regulatory compliance activities.
• Provide guidance and training on regulatory systems, processes, and best practices.
• Mentor less experienced team members and contribute to continuous learning within the Regulatory Affairs organization.

Candidate Profile
• Education : Bachelor's degree in Regulatory Affairs, Life Sciences or a related field.
• Experience : Minimum 4-8 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Data Management, Quality Systems, or a related function within the medical device, pharmaceutical, biotechnology, or other regulated industry.
• Technical Knowledge: Working knowledge of FDA regulations, including Quality Management system regulation.
• Advanced proficiency with Microsoft Excel; experience with analytical tools preferred.

Key Competencies
• Regulatory operations expertise
• Data integrity and data governance
• Process improvement and continuous improvement
• Analytical thinking and problem-solving
• Cross-functional collaboration
• Effective written and verbal communication
• Organizational and prioritization skills
• Ability to manage multiple projects and deadlines
• Leadership and mentoring capability

Additional Information
Experience : Minimum 4-8 years
Qualification : Bachelor's degree in Regulatory Affairs, Life Sciences
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 30th October 2026