Principal Clinical Research Associate (In-House Principal CRA)
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Develops site and study documentation such as training materials, protocols, plans, tracking reports, study manuals, and regulatory submissions for clinical research studies In-house monitoring to study and procedure instructions of CRF’s and study regulatory files Support Clinical staff for audit readiness and preparations […]
Manufacturing Engineer
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Senior technical resource for processes, systems, and equipment for Manufacturing Engineering at Elixir. Develop new processes, optimize existing processes and systems, and design for future requirements Develop Manufacturing Engineering projects to improve quality, capacity, and cost. Lead cross-functional stakeholder groups for projects. Analyze […]
Sr. Product Manager
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Global launch planning and execution for novel and innovative interventional cardiology devices, including launch readiness, sales training, messaging, competitive positioning and materials development. Support on-market activities in collaboration with Commercial teams aligned with product strategy and target customer segments. Build and execute new […]
Manufacturing Technician
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Manufacture commercial, prototype, pre-clinical and clinical units in a Cleanroom Environment. Includes stent preparation, cleaning, and coating, catheter preparation and stent mounting, device inspection, and packaging Operate computer-controlled machinery Complete manufacturing documentation such as Lot History Records (LHR) in compliance with Good Documentation […]
Junior Customer Service Representative
Major Duties and Responsibilities The Customer Service Representative supports the day-to-day customer order process and provides frontline service to internal teams and external customers. Responsibilities include, but are not limited to: Customer Excellence Process customer orders accurately and on time, ensuring alignment across Sales, Marketing, Operations, and Finance. Monitor and track order status, escalating discrepancies […]
Accounting Manager
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Plan and manage all activities of the general accounting function to ensure accurate and timely recording and reporting of all financial results in accordance with U.S. GAAP Lead and manage the entire financial close process, including payroll (position would own ADP payroll processing) […]
Principal Regulatory Affairs Specialist
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Prepare and submit global regulatory applications that support clinical research and marketing approvals in accordance with the company’s strategic objectives Formulate and implement regulatory strategy, provide guidance, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet […]
Senior Manufacturing Engineer
Major Duties and Responsibilities Responsibilities will include, but not be limited to: Senior technical resource for processes, systems, and equipment for Manufacturing Engineering at Elixir. Requires detailed technical knowledge of processes and systems. Must be able to develop new processes, optimize existing processes and systems, and design for future requirements Develop Manufacturing Engineering projects to […]
Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease
Elixir Medical today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System.