The Product Surveillance Director sustains a center of excellence in medical device and combination product complaint handling. This includes, but is not limited to, developing global Product Surveillance organizational design, process strategy, procedures/processes, program goals, and metrics to ensure ongoing compliance and drive measurable improvements in complaint handling and the customer experience. This function is responsible for the overall compliance and consistency of the complaint handling process and all reported complaints (medical and product quality). In consultation with other functions, this function will escalate any identified potential product and safety issues through management review, investigations and, where appropriate, Agency correspondence. The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements, including knowledge of 21 CFR 820, ISO 13485, ISO 14971, and any other applicable regulations/guidance.
Main Areas of Responsibilities
Ensure complaint investigation and processing of complaint/adverse event files including associated claims follow global complaint handling regulations and internal procedures. Ability to analyze information obtained and make decisions for reportability under MOR regulation, 21 CFR 803, CMDR SOR/98-282, ISO 9001, IS013485:2003 and international vigilance regulations.
Serve as Subject Matter Expert for the complaint handling process.
Oversee global complaint handling process, to ensure complaints related to medical devices arc appropriately handled, evaluated, and reported to regulatory Agencies worldwide.
Coordinate and oversee regional complaint coordination process.
Analyze and monitor costs associated with complaint handling and Device Tracking.
Communicate and collaborate with Quality Assurance Device Safely, Product Development, Customer Care, Operations (manufacturing facilities), Finance, ROIS, Medical Affairs. WWQA, Sales and Marketing departments to ensure corporate goals and strategies related to complaint handling are met.
Establish annual budgets and quarterly forecasts. Make necessary changes to assure annual budgets are met, and/or reforecast in accordance with management and finance approvals.
Provide generalized company, departmental and product knowledge as required.
Respond to verbal and written requests from Regulatory Agencies and internal and external customers, as needed.
Handle escalated conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service. Resolve customer concerns with potentially litigious issues.
Generate "talking points" and other documents that effectively communicate corporate policies and directives.
Provide generalized company, departmental, and product knowledge as required
Monitor apartment processes Ana workflow for opportunities for improvement and optimization.
Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
Ensure timely integration of complaint handling for acquired or newly launched products.
Ensure that all team members receive appropriate and timely training.
Establish a standard process to escalate incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task owner.
Chair relevant complaint review meetings to drive closure and meet reporting timeline requirements.
Direct call queue management to improve upon customer experiences using business analytics and call metrics.
Manage and provide product complaint KPI reports to Product Management and Business Unit Management. Hold Tier meetings across PS to ensure metrics are clearly visible and operations maintain within control.
Manage the global complaint handling procedures and processes to ensure that all are up-to-date and effective. Implement appropriate enhancements, as necessary.
Direct management and teams to continually evaluate current policies, procedures, and practices to develop and implement improvements.
Represent the complaint handling functions during internal and external audits and inspections
Establish performance metrics to ensure case-files are completed timely and service levels are met. Monitor quality of employee customer calls, ensuring that the highest level of service is given.
Monitor work flow to ensure quantity and quality are consistently met. Continually initiate plans to maximize use of resources, and/or take corrective action to resolve problems to accomplish department tasks and goals.
Review administrative procedures and systems for improvements. Write or revise policies and procedures in accordance with FDA and Vigilance regulations and ensure completion through the change control process.
Conduct supervisory activities such as interviewing/hiring new employees, processing time records and vacation/absence requests, producing and administering performance evaluations and any employee disciplinary actions.
Assess and define department training needs. Confirm all training needs are met, and process training records.
Ensure that the area and equipment are operating safely and notify responsible person to make changes to maintain a safe area. Monitor safety procedures for compliance with company procedures.
Perform monthly audits of complaint handling files to ensure conformance with requirements.
The following listed requirements need to be met at a minimum level to be considered for the job:
Bachelor's degree or equivalent in a Life Science, Engineering or Physical Sciences. Advanced degree is desired.
Experience of ten or more years of progressive quality, engineering or compliance with at least five years in a managerial capacity.
Previous experience in medical device complaint management, product surveillance, and regulatory event reporting.
The below skills are attributes that may not be mandatory but are desired in the ideal candidate.
Demonstrated knowledge and application of medical device adverse event reporting requirements including 21 CFR 820 & 821,18013485, 1801497, Canadian Medical Device regulations, Australian TGA regulations, European Medical Device Directives, ICH/GCP Guidelines and other international standards.
Strong technical knowledge of supported medical device and combination product lines.
Excellent written, verbal, listening, communication and team building skills.
Demonstrated ability to work effectively with and lead cross-functional teams
Ability to effectively prioritize and manage multiple project workloads.
Experience with trending and analysis reporting.
Demonstrated ability to manage people.
Demonstrated ability in Project Management.
Knowledge of the Adverse Event Reporting. Complaint Investigation, CAPA, and Field Corrective Action processes.
Ability to influence without authority.
Managing and measuring work.
Effective communication and collaboration skills.
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions, write reports; and give oral presentations.
Sense of urgency and intellectual curiosity.
Continuous Process Improvement.