A stakeholder in ZOLL's Quality Assurance complaint handling process in accordance with the FDA’s Quality System Regulation (QSR)/ Good Manufacturing Practices (GMP) and globally harmonized standard ISO 13485. Reviews and assesses complaint information received from Technical Support. Based on information received, determines if events meet appropriate regulatory requirements for adverse event reporting. Generate appropriate regulatory reports based on assessment, communicate with other Sub-Office departments globally and respond to regulatory authority requests. This involves written documentation, computer input and interactions with internal and external customers. This position performs evaluations, preparations for audits, review and submission of regulatory documents and some oversight of the regulatory affairs program. In addition to creating and maintaining UDI related information in multiple systems. Providing UDI GTIN data to External and Internal Customers. Position will require reconciliation and auditing of the UDI related information and assisting in future UDI projects.
Required Education and Experience:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.