What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
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.
Qualifications
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
What is expected of you and others at this level
Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
Works on projects of low to moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes action to resolve
Applies judgment within defined parameters
Receives general guidance and may receive more detailed instruction on new projects
Serves as a resource for junior 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.
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