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Position Summary:
Under direction of the department manager, provides technical assistance to customers and Werfen field personnel within a product line responsibility. Troubleshoots, over the phone, answers a broad range of technical questions regarding instrument performance, instrument capabilities, QC concerns and other product concerns as required. Assists in the training and direction of new personnel within the department.
Market Access Manager (INOVA Diagnostics, Inc. d/b/a Werfen Autoimmunity, San Diego, CA): On behalf of a worldwide developer, manufacturer, and distributor of specialized diagnostic instruments and reagents for Autoimmunity products and services, responsible for developing and implementing market access strategy and tactics into a continuously evolving healthcare environment. Serve as key contributor of the overall commercialization effort of new and existing Autoimmunity systems and reagents and provide guidance and support on related product development activities and collaboration with key opinion leaders.
Position Summary:
Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) 217/46, as well as other country regulatory agencies. Represents regulatory on design teams, prepares regulatory plans, authors US FDA 510(k)s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion. Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.
Position Summary:
Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) 217/46, as well as other country regulatory agencies. Represents regulatory on design teams, prepares regulatory plans, authors US FDA 510(k)s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion. Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.
Amazing Total Rewards for our Field Service Team!
- Generous Base Salary + Incentive Compensation
- Company Vehicle with Personal Use Allowance
- Phone & Internet Reimbursement
- 8% 401k Match (dollar for dollar!)
- Comprehensive Health Care Benefits
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Job Summary
Patient Blood Management (PBM) Specialists are responsible for Rotem and VerifyNow instrument and P&E revenue growth within their assigned geography. To grow revenue, PBM Specialists will present health economic and clinical information, IT solutions, and instrument demonstrations to hospital departments associated with transfusion and Patient Blood Management including the cardiac operating room, transplant, trauma, blood bank, laboratory, and purchasing. Additionally, PBM specialists will build physician...
Position Summary:
The Calibration and Plant Services Coordinator is responsible for administering the SAP Plant Tool System for tracking Calibration and Maintenance records for all equipment within the plant. The Calibration and Plant Services Coordinator is also responsible for maintaining the spare parts catalog, scheduling with service vendors and procurement of machine and facilities related parts.
Amazing Total Rewards for our Field Service Team!
- Generous Base Salary + Incentive Compensation
- Company Vehicle with Personal Use Allowance
- Phone & Internet Reimbursement
- 8% 401k Match (dollar for dollar!)
- Comprehensive Health Care Benefits
-
The Transfusion Global Marketing Product Manager will be responsbile for collaborating closely with cross functional teams to identify market needs to support new product development projects to assist in growing the Transfusion revenue globally. This position will also manage global implementation of new product development projects while working closely with the Global Commercial Marketing organization. This position will also be responsbile for ongoing lifecycle management activities to support buiness continuity, including, but not limited to supporting post market survillance acitivities.
Job Summary
The Director of Sales, Business Unit is responsible for national sales, budgeting, and expenses management within Werfen's North American Commercial Operations for their assigned Business Unit. In this high-level leadership position, the Business Unit Director will influence, develop, and implement long-term strategies and key performance indicators. This role requires high levels of collaboration with internal customers as...
Position Summary:
Performs analyses of Clinical Chemistry, Critical Care, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality standards and GMP requirements
Job Summary
The position is responsible to ensure that the Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our SaMD, SiMD and Digital products. This position provides project-level leadership, develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development,
Position Summary
The position is responsible to ensure that activities throughout the product lifecycle are compliant with procedures, standards, and regulations applicable to our products. The position works independently and with guidance from manager develops, applies, and implements methods, tools, and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance, and service.
This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement,...
We are looking for a Biologics Procurement Specialist manages the Reagent Donor Program including developing donor schedules to meet production schedule needs and communicating with donors and collection facilities to ensure blood collected is received in a timely manner. As a Biologics Procurement Specialist, is responsible for scheduling donors to meet Werfen's survey needs, managing donors samples sent for external testing and assist internal customers with red cell requests. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!
Job Summary
The International Customer Service Coordinator I is responsible for processing all customer orders in the system with a high level of accuracy.This role involves issuing credit and debit requests, entering system tickets for discrepancies and interacting with the sales team as needed. The primary focus of this role is ensuring precise and timely order entry.
Werfen
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly...
Position Summary:
Performs analyses of Clinical Chemistry, Co-Oximeter, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality and GMP requirements.
Position Summary:
Performs analyses of Clinical Chemistry, Co-Oximeter, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality and GMP requirements.
Position Summary:
ThisProduct Manager position is