Open Positions
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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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.
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 […]
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 […]
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.
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 […]