Responsibilities: The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials This role is key to implementing programming standards and...
Responsibilities: Leads, performs, and oversees data management activities for clinical studies and/or clinical programs Performs hands-on clinical data management tasks to support clinical studies, including, but not limited to reviewin...
Responsibilities: Ensure departmental or functional training plans in place and appropriate. Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time del...
Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best p...
Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best p...
Responsibilities: The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards an...
Job Description: Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownersh...
Responsibilities: Manufacturing Engineer, GMP, FDA, KPI, ISO Standards, Six Sigma, Lean Methodology, Risk management, Validation processes, Manufacturing Automation. Lead manufacturing programs to drive process improvements, cost reducti...
Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Par...
Roles & Responsibilities: Experience in drafting protocols & report generation (including Data Analysis). Experience working in a medical device manufacturing environment. PLM/PDM/ERP experience preferably Windchill. Good experience in...
Roles & Responsibilities: Software quality assurance or software validation. Preferably within the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304. Experience in non-product software validation. ...