Open Positions
Manager / Director, Clinical Research
The Manager/Director, Clinical Research is responsible for leading and driving clinical trial execution for multiple studies to ensure all assigned trial deliverables across programs are completed according to timelines, budget, applicable regulations, quality standards, SOPs and business guidelines. This individual will be a strategic thinker, problem-solver and is accountable for identifying risks and developing risk mitigation strategies. Must demonstrate significant expertise in the successful planning, implementation, and execution of a broad portfolio of global clinical trial operations. Exceptional critical thinking and problem-solving is a must.
Manager, Clinical Data Management
Manager, Clinical Data Management Major Duties and Responsibilities
Responsibilities will include, but not be limited • Serve as the domain expert in providing clinical data management and electronic data capture (EDC) expertise to support clinical studies
• Design the case report forms (CRFs) in collaboration with the clinical operations team according to clinical protocol and study data requirements
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Clinical Research Associate
Clinical Research Associate Major Duties and Responsibilities
Responsibilities will include, but not be limited to ensures timely collection of study documentation by obtaining, maintaining, and controlling all necessary records and documentation according to procedures and regulations Maintains documentation in the Trial Master File (TMF) for all assigned clinical studies according to internal procedures and regulations. Duties may include electronic and hardcopy file maintenance [….]
Associate Director/Director Clinical Science
The Associate Director/Director Clinical Scientist provides scientific expertise throughout the development and implementation of clinical evaluations, risk management and /or clinical studies.
Senior Quality Technician
Senior Quality Technician, Major Duties & Responsibilities will include, but not be limited to inspect/test components as part of incoming inspection. Use common QC inspection tools such as micro-balances, calipers/micrometers, pin gages, rulers, thickness gages, thermometers, timers, vacuum/pressure gages, optical measurement machines. Perform quality review of Lot History Files (LHRs) […]
Manufacturing Engineer
Manufacturing Engineer Major Duties and Responsibilities will include, but not be limited to contribute to cross-functional groups (Engineering, Quality, R&D, etc.) to resolve complex, cross-functional technical issues affecting production. Monitor metrics for product yield, cost and throughput; Contribute to efforts to improve in all three categories utilizing lean manufacturing principles […]
Sr. Analytical Chemist
SR. Analytical Chemist Major Duties and Responsibilities will include, but not be limited to perform analytical chemistry research to develop assays based on new and existing methodologies. Develop and validate testing methodology used to control raw materials, production intermediates and final products […]
Director, Regulatory Affairs
Director, Regulatory Affairs Major Duties and Responsibilities will include, but not be limited to develop and implement global regulatory strategies that support clinical research and marketing approvals in accordance with the company’s strategic objectives. Work directly and interactively with cross functional teams during product development phases interpreting regulations, analyzing risks, and providing direction on test strategies and reviews thereof. Define strategies to mitigate risks […]
Manager, Regulatory Affairs
Manager, Regulatory Affairs Major Duties and Responsibilities will include, but not be limited to develop and implement global regulatory strategies that support clinical research and marketing approvals in accordance with the company’s strategic objectives. Work directly and interactively with cross functional teams during product development phases interpreting regulations, analyzing risks, and providing direction on test strategies and reviews thereof. Define strategies to mitigate risks […]
Manager / Sr. Manager, Clinical Research
The Manager / Sr. Manager, Clinical Research is responsible for leading and driving clinical trial execution for multiple studies to ensure all assigned trial deliverables across programs are completed according to timelines, budget, applicable regulations, quality standards, SOPs and business guidelines. This individual will be a strategic thinker, problem-solver and is accountable for identifying risks and developing risk mitigation strategies. Must demonstrate significant expertise in the successful planning, implementation, and execution of a broad portfolio of global clinical trial operations. Exceptional critical thinking and problem-solving is a must.
Manufacturing Technician
Manufacturing Technician Major Duties and Responsibilities will include, but not be limited to manufacture prototypes, pre-clinical and clinical units. Includes stent preparation, cleaning, and coating, catheter preparation and stent mounting, device inspection, and packaging. Perform preventive maintenance as required for production equipment[…]
Regulatory Affairs Specialist
The Regulatory Affairs Specialist supports the regulatory activities required for global market entry and patient access for Elixir Medical’s growing product portfolio. In this role they will contribute to the development and updating of regulatory strategies, submission, and documents based upon regulatory changes. This position performs specialized level work assignments in the evaluation, preparation, and submission of documentation for worldwide regulatory registrations, ensuring products and procedures comply with regulatory requirements.
Senior Director, Quality and Regulatory
The Senior Director of Quality and Regulatory is responsible for overseeing all aspects of the Quality System in support of the development and manufacturing of Elixir Medical’s innovative product portfolio. The successful candidate will lead the quality management system/infrastructure that is compliant, effective, efficient and agile that supports a growing international business with multiple product lines. They will provide quality management oversight for all elements of Elixir Medical’s Quality Management System (QMS). Oversight includes quality engineering, design controls, risk management, corrective and preventive action, training, document control, and production quality controls.
Manager / Director, Research & Development
Manager / Director, Research & Development Major Duties and Responsibilities Responsibilities will include, but not be limited to: Identify market opportunities and propose/generate product projects to satisfy these opportunities in line with company goals Establish timing and performance goals for product projects Oversee and/or contribute to R&D project efforts Identify and research new technologies Initiate […]