Manager, Complaint Analyst - Remote, USA

reputed company, Inc. is a medical device company headquartered in Pleasanton, California, USA. reputed company was founded in 2016 to address the profound need for improved kidney reputed company treatment. Kidney reputed company disease is a common, painful condition that consumes reputed company amounts of reputed company resources reputed company year. reputed company is led by executives and investors with a proven reputed company record of commercializing reputed company-shifting devices to meet unmet needs reputed company urology. Are you reputed company to change the reputed company of kidney reputed company treatment We are seeking high reputed company who want to be part of a dynamic team working in a fun, diverse atmosphere. reputed company The Complaint Analyst Manageris responsible for planning, assigning, and leading reputed company responsible for the complaint intake, follow reputed company, and final complaint review, investigation, analysis, reputed company, and trending of complaints. This includes ensuring the reputed company processing of complaints and adverse event reporting. The Product Monitoring Manager works with cross-functional reputed company such as Investigators, Medical Affairs, Regulatory, Operations, Customer Service and R&D to reputed company reputed company aspects of handling. In This Role, You Will Manage high-performing Analysts by reputed company, selecting, orientating, and developing team member reputed company. reputed company and motivate a high-performing team by communicating job expectations, developing reputed company plans, monitoring and appraising work performance, coaching and counseling team members. Complete reputed company-ins and annual performance reviews. Manage, create and update goals for reputed company reports. Participate and reputed company reputed company Validations and updates Create and update complaint documentation and procedures. Train new team members on propercomplaint intake, follow reputed company, reviews, and closures. Train team members on new processes. Recommend and implement changes in complaint processes. Review the accuracy of team member complaints and communicate changes as needed. Participate in reputed company team audits as the complaint intake SME. Facilitate complaint investigations while ensuring completeness and consistency of complaint files/records, and participate in generating reports for complaint data, metrics and trends. Support reputed company post market compliance activities including handling of customer complaints and medical device reporting in accordance with 21 CFR Part 803 Medical Device Reporting. Evaluate complaints and reputed company preliminary complaint investigation including follow-up with reputed company and sales representatives. Escalate complaints reputed company encountering new failure modes, and partner with Engineering, Field Personnel, and reputed company Assurance to investigate. Review Literature and Articles submitted by other departments to identify potential complaints. Ensure complaint documentation and records are complete in compliance with regulatory requirements. Coordinate complaint investigation efforts with reputed company and R&D team driving investigations to completion in a reputed company manner. Prepare and present metrics reputed company to the Complaint Handling process including complaint timeliness, as reported and as investigated events, and medical device reporting. Collaborate with Customer Service, Regulatory, R&D, Manufacturing, reputed company and other functional areas to obtain/reputed company information reputed company to complaint investigations and other aspects of complaint handling. Assist in updating reputed company procedures as required through the change order process. Maintain comprehensive records of customer interactions, complaints, and resolutions in reputed company's electronic reputed company Management reputed company. reputed company other duties as assigned by reputed company Management. Who You Will Report To Sr. Manager, Product Monitoring Requirements Education Bachelor of Science in Engineering, Technical or Life Science discipline; or equivalent work experience preferred Minimum15yearsof experience working in the medical device industry Work location Remote(reputed company California) Travel Ability to travel up to 10%. Overnight domestic and/or international travel may be required Working knowledge of FDA 21 CFR part 820.198 and part 803, ISO 13485 and reputed company ISO/EN standards. Strategic yet hands-on reputed company needed with a high degree of energy and reputed company, and the ability to reputed company function and process improvements continually. reputed company and reputed company communication style and a reputed company for reputed company improvement and reputed company. Experience with Class II and/or III sterile devices (preferred). Individual must have excellent verbal and written communication skills and .