The role of the Post Market Vigilance (PMV) Specialist encompasses the responsibilities described below and builds in additional functions, based on experience and proven aptitude. The PMV Specialist is to be an expert in the functioning and application of Magellan Diagnostics' products. This knowledge will be used to support all postmarket complaince activities including customer complaint handling, Medical Device Reports (MDR) / Vigilance Reports (MDV), and to participate in the team that provides technical product support as well as product training to internal and external customers, as needed. Users including nurses, doctors, and laboratory technicians as well as sales, marketing and other personnel.
* Responsible for managing, processing and closing product complaints utilizing product knowledge and technical expertise. * Performs review of complaints received for completeness and accuracy. * Makes and documents decisions, within established timelines, related to worldwide regulatory reporting and provides notification as required. * Communicates with customer/complainant to acknowledge, document and investigate reported adverse events. * Conducts, documents and summarizes results of product failure analysis. * Compiles assigned complaint investigation and failure analysis information into an investigation report, documents root cause, applies event codes and routes complaint investigation reports for approvals per established timelines. * Will submit MDRs and MDVs where serious adverse events have occurred. * Applies knowledge of medical device regulatory requirements in order to support the MDR reporting process and identifying reportable events as they are received. * Produces worldwide vigilance report forms in accordance with worldwide requirements and submits to appropriate regulatory agency within required timelines. * Support communication to inquiries from various regulatory bodies. * Ensure that complaint files documented in accordance with GCP, GDP and GMP requirements. * Work with product repair and failure investigators to ensure timely and effective investigation. * Acts as a Quality Control Specialist on complaint closure. * Serves as a technical Subject Matter Expert (SME) for Complaint team interfacing with Failure Analysis organization.
* Responsible for managing, processing and closing product complaints utilizing product knowledge and technical expertise. * Review and evaluate clients product complaints in accordance with established operating procedures and applicable US and International medical device regulations. * Conduct laboratory investigations required to assess and understand customer complaints, for tracking and closing complaint investigations. * Working with Quality Assurance to properly escalate complaints in the quality management system. * This individual must have knowledge of specific laboratory techniques and instruments and must be able to recognize factors that directly affect procedures and results. * The PMV Specialist is also called upon to report lab results internally (to PS Manager, R&D, engineering, and QA), maintain equipment, and maintain laboratory records, as well as to use the company's CRM system to document customer interactions. * The PMV Specialist understands lab licensing and CLIA regulations, as well as regulatory requirements (ISO, FDA). * The PMV Specialist should have excellent telephone communication skills and the ability to work independently as well as in a team.
Essential Functions: Compliance to regulatory reporting requirement regarding customer complaints and MDR. The PMV specialist will ensure timely reporting, investigation of customer complaints. Follow-up customer satisfaction is the key responsibility of this department and this role. The Product Support Team is required to provide ongoing support required to maintain customer satisfaction.
Supervisory Responsibilities: N/A
Success Factors: Excellent oral and written communication skills, especially over the telephone, to assist and train customers with product implementation and ongoing use. Must be able to diplomatically and thoughtfully overcome objections, handle difficult conversations, and resolve problems. A focus on customer experience and satisfaction is key to success in this role. Requires critical thinking skills, good judgment, flexibility and the ability to work unsupervised or with minimal supervision. Must be able to be work in a fast-paced environment and take appropriate action and have the ability to manage work on multiple projects with various urgency and deadlines. The ability to work through conflict resolution as a member/or leader of a project team is essential.
Minimum Qualifications / Education: Bachelor of Science degree in a life science and/or Medical Technology. 1 - 3 years experience with a broad knowledge of chemistry/biochemistry or other life science; or equivlaent industry experience.
Computer Skills: Microsoft Office (particularly Word and Excel), Outlook, exposure to a Customer Relations Module
Work Environment: Typical clinical laboratory conditions as well as office environment.
Physical Requirements: Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.
Associated topics: hematopathology, lab, medical laboratory science, mlt, molecular, services, sterile processing technician, technician i, technician laboratory, toxicology
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.