1. Assist management in the development, implementation, and maintaince of software and cybersecurity framework and procedures to maintain and ensure compliance with medical device regulatory requirements. 2. Coordinate, compile, and maintain U.S, and/or International regulatory facility registrations, product listings/licenses and other country specific product registrat

Provide customer support through email and phone calls via ZenDesk and Five9. Manage a sales region of service contracts and software maintenance agreements throughout lifecycle. Set up new warranty contracts in Metrix upon instrument installation. Generate service renewal contracts, reviewing terms of new contract against master or original sale contract. Validate data,

1. Supports the development and maintenance of key aspects within Sysmex's quality systems, designed to meet the Quality Management System requirements and ensure compliance with Regulatory requirements. 2. Day to day management and coordination of (any of these can apply) Coordinate effective corrective and preventive (CAPA) actions with various business owners, includin

1. Maintain product knowledge on all SAI supported instruments in order to analyze and identify instrument problems. 2. Adhere to all SAI and department standard operating procedures and documentation requirements to meet regulatory and ISO guidelines. Such as, escalated calls when appropriate and monitor TAC voicemails, auto generated errors, dispatches and overflow call

1. Follow documented processes and procedures to determine consistently accurate and traceable assay values of commercial blood products used for daily QC and calibration by Sysmex customers. Establish and report such target values for QC materials according to production schedules. 2. Adhere to policies and procedures and maintain good laboratory practices. Document acti

1. Leads preparation, documentation and submission of FDA and Health Canada applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes 2. Manages maintenance of

1. System Administration and Validation (40%) Manages the talent management system through systems support, overseeing the day to day operations, and implementing processes related to system modules. Masters and maintains detailed knowledge of talent management product suite with an awareness of opportunities to expand solutions and services and performs the Superuser rol

1. Execute and implement R&D projects to meet objectives following timelines. 2. Conduct measurements; utilizing existing or new technologies, perform experiments and data analysis, mainly focusing on measurements. 3. Develop and evaluate novel assays; develop and evaluate novel assays to measure new analytes and reactions, primarily using in house measurement platforms.

1. Facilitate learning for Sysmex customers via Virtual instructor led classes (VILT) in an on line setting using Zoom Meeting content delivery system and live on camera streaming technology in a studio based laboratory environment. 2. Occasional Instructor led classes in a traditional classroom setting. 3. Collaborate with the CFL Instructional Design team in the develop

Day to day management and responsibility for strategy and tactical execution of urinalysis systems Internal and external champion of UA product lines Manages activities to ensure that technical materials, white papers, sales tools, product launch materials and training materials are developed as appropriate Develops "anti competitive" materials and updates for commercial

1. Prepare, write and document submissions for FDA and Health Canada applications. Responds to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. 2. Review all regulatory materials to guarantee accuracy, timeliness, comprehensiveness, and compliance with regulatory standards. 3. C

General Load and unload all inbound and outbound trailers, trucks, vans, making sure all safety devices are utilized and distribution center procedures are being followed. Conduct daily cycle counts and physical inventories. Consolidate product to optimize space in the warehouse. Awareness of all products and product handling requirements. Monitoring warehouse inventory l