職位描述
工作職責(zé):
This new position of Director, Post Market Surveillance (PMS) is accountable for overall strategy, execution and oversight of all activities associated with complaint handling associated quality management systems, functions and regulatory compliance reporting of Adverse Events (AEs) and Medical Device Reportable (MDRs) throughout the product life cycle for MicroPort Cardiovascular business, globally.
? This key leadership role is to ensure governmental regulatory requirements are met, customer experiences are appropriately logged and investigated to both comply with laws/regulations. This position will facilitate proactive quality and associated improvements in customer experience, as well as to ensure the organization is informed of adverse trending through analysis of complaints for Adverse Events, Medical Device Reportable, including tracking and trending.
? Direct leadership accountability and oversight of activities such as (a) uptake and logging of customer complaints, (b) their proper and thorough investigation and subsequent documentation, (c) statistical tracking and trending and associated evaluation and escalation of adverse customer complaint trends and early identification of new issues (with priority on safety issues), (d) proper evaluation of safety and patient risk through overall administration of a Health Hazard Evaluation (HHE) process, and (e) AE and MDR reporting, and the associated timeliness.
? Assures compliance with regards to AE/MDR with the applicable international regulatory requirements (ie, FDA QSRs, ISO 13485, Japanese MHLW, Brazilian ANVISA, EU MDR) for the company
s products, including medical devices, and combination products. Ensures successful internal and external inspections and audits.
? Ensure timeliness of all complaint handling, adverse events, and medical device reporting activities in accordance to procedures, standards and regulations.
? Responsible and accountable for the compliance of all PMS processes and procedures, associated document and performance metrics.
