Senior Regulatory Specialist, Data Management & Governance

What Regulatory Affairs contributes to Cardinal Health

Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.

Regulatory Affairs plans, coordinates and implement regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.

Job Summary
The Senior Regulatory Specialist, Data Management & Governance for Medical Devices plays a critical role in ensuring that Cardinal Health’s data practices and all data generated, processed, and submitted by the organization, comply with regulations set by agencies such as the U.S. Food and Drug Administration (FDA) and the European Union under the EU 2017/745 Medical Device Regulation (EU MDR) and meets the stringent quality and integrity standards. The ideal candidate will have expertise in data governance principles and a thorough understanding of the regulations governing the medical device industry, including those from This role requires close collaboration with cross-functional teams to implement a robust and auditable data lifecycle. 

The ideal candidate will be in the Waukegan, IL location.

Responsibilities

• Interpret complex regulatory requirements (e.g., FDA 21 CFR Part 820, 21 CFR Part 11, EU MDR, and ISO 13485) related to data management into clear, actionable data governance policies and standard operating procedures (SOPs).

• Monitor the evolving regulatory landscape and communicate potential impacts to the organization's data practices. Develop and implement strategies to ensure that the collection, storage, and processing of all device-related data meet these standards.

• Manages the integrity of regulatory data used for regulatory submissions, clinical evaluations and post-market surveillance. This includes ensuring data is complete, accurate, consistent, and traceable.

• Support and lead data integrity initiatives to ensure the accuracy, completeness, and reliability of all GxP data, through lifecycle of the device from design to manufacturing and post-market.

• Establish data quality metrics and monitoring processes to proactively identify and remediate issues across different data systems and records.

• Manage and enforce data provenance, ensuring a complete audit trail of a dataset's origin, transformations, and access for regulatory reporting.

• Support the validation of computer systems used for GxP data to ensure they comply with FDA 21 CFR Part 11 regarding electronic records and signatures. Oversee the metadata management and data cataloging efforts to ensure transparency and consistency across all regulatory data assets.

• Conduct data-related risk assessments to identify vulnerabilities and propose mitigation strategies to ensure compliance with data integrity regulations and work with cross-functional teams to investigate and resolve data integrity issues and non-conformances.

• Serves as a subject matter expert during internal and external audits conducted by regulatory agencies. This includes preparing and presenting documentation related to the company's data management and governance practices.

• Collaborate with the IT department and system owners to define data classification, access controls, and retention policies in accordance with regulatory requirements. Acts as a liaison between the regulatory department and other functions, such as R&D, Quality Assurance, Marketing and Legal, to ensure that regulatory requirements for data are addressed across all parts of the organization. 

Qualification:

• Bachelor's degree in a related technical or scientific field, such as Information Systems, Computer Science, Regulatory Affairs, preferred or equivalent work experience

• RAC certification is a plus.

• 2-4 years of experience in data governance, quality assurance, or regulatory compliance role within the medical device or a highly regulated life sciences industry, preferred

• In-depth knowledge of U.S. and EU medical device regulations, especially requirements concerning data integrity, clinical data, and post-market surveillance, preferred

• Experience in data operations, data quality, or data stewardship, preferably within the life sciences or healthcare industries, preferred

• Excellent ability to review and interpret complex data,