Job Description: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs acti...
Responsibilities: Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP. Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets. Execution of validation and...
Job Description: The Sr. Regulatory Specialist is responsible for supporting client product and product development and regulatory activities to commercialize new digital products, including AI technologies. In this role, the Sr. Regulator...
Responsibilities: Labware SME, AWS Cloud Operational experience, deploy Labware, configuration, Migration testing, validation, qualification. Business requirements optimization. Analyse and document customer requirements and business pr...
Job Description: We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and validation of clinical trial da...
Responsibilities: Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with Quality Management System (QMS) expectations. Navigate complex change review discussion...
Roles & Responsibilities: Ensure quality engineering activities for released products comply with regulatory and internal standards. Collaborate with cross-functional teams to develop product risk management documentation, including Risk...
Job Description: We are looking for an experienced GxP Compliance Test Led to join our team in Raritan, NJ. The ideal candidate will have deep expertise in GxP regulations, computer system validation (CSV), and quality compliance within ph...
Job Description: The CSV Engineer will support the generation, execution, and documentation of qualification activities for Emerson DeltaV (Client), Siemens PLC, and other GMP automation systems. This role ensures all validation and qual...
Responsibilities: Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. Provide strategic oversight and direction to CRO clinical data m...