Description: looking for a candidate with experience in Clinical Data Management and Biostatistics departments. Focuses on Incident, Problem, and Change is responsible for the ownership and management of these processes Lead major incid...
Responsibilities: Evaluates customer complaints, including the coordination of documentation review, sample testing, and root cause analysis. Leads and/or facilitates the compliant investigation to reduce or eliminate causes of the compl...
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,...
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 ...
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...
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...
needed. They will be responsible for the full life cycle of the CAPA from root cause analysis, to writing the investigation...
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...
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...