Responsibilities: Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting. Develop and manage data management timelines for multiple projects, ensuring all milestones...
Job Description: This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements. The Sen...
Job Description: Material Handler II is responsible for the safe, accurate loading and unloading of product within the distribution center. The following duties and responsibilities are intended to be representative of the work performed b...
Job Summary: The CSV Engineer will be responsible for validating ERP, SAP, and MES manufacturing applications in a regulated environment. The role involves ensuring compliance with GxP standards through risk-based validation, supporting...
Job Description: Responsibility for the Quality and Compliance of process development and manufacturing of implantable ( Class III) Cardiac and Neuromodulation medical device related products. Initial scope of work may be focused on Inspec...
Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ...
Roles and Responsibilities: Strong technical writing and documentation skills. Ability to gather requirements and inputs from SMEs and project teams. Experience in Life Sciences / Pharma / Biotech. Experience as a Test Lead (Manual & A...
Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class...
Summary: We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance, regulatory compliance, and continuous improvement initiatives. The ideal candidate will have a strong background in FDA...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...