initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle;track...
guidance and support to site quality teams in process implementation. Requirements: Bachelor's degree in LifeSciences...
Roles & Responsibilities: 2+in Years in Medical Device Industry. Lead and or support early innovation / proof of concept development work. Develop 3D CAD models using Solidworks or similar CAD modelling platforms. With guidance f...
Responsibilities: Performs data management activities for both clinical studies and development projects as assigned. Ensures the delivery of complete, accurate data that is ready for analysis and regulatory submission. Supports all dat...
Roles & Responsibilities: Bachelor's degree or equivalent plus 4 +years of related work experience or equivalent combination Engages cross functionally to investigate and document compliance events, ensuring timely resolution to ena...
Responsibilities: Working knowledge of FDA and European medical device regulations (QSR and ISO) is required. Working knowledge of software validation requirements for software used in the production of medical devices and software used ...
Responsibilities: Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management. Demonstrate expertise by leading cross-functional teams to identify risks,...
needed. They will be responsible for the full life cycle of the CAPA from root cause analysis, to writing the investigation...
Responsibilities: Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant. Manages multiple and complex CQV projects, provides status reports and coordinates with ...
Job description: The Clinical Research Nurse is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Assists with the execution of study-related activities of a Phase I clin...