Responsibilities: 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 act...
Job description: This role demands technical expertise and soft skills to provide guidance and leadership to suppliers and internal customers to promptly resolve supplier quality issues and ensure a seamless transition of new products int...
Roles & Responsibilities: Bachelor's degree in engineering or related field. Minimum 4+years of experience in supplier quality engineering within the medical device industry. ISO 13485 Certified Talent preferred by client. Strong...
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...
Consulting engagement - will work closely with the COO to create a flexible model to support their M&A activity. The model will be built in MS Excel and needs to be flexible to allow the organization to model out different scenarios associa...
Responsibilities: Enablon Support Specialist. Domain expert on Environmental Sustainability and Management, specialist on Enablon. Support Specialist with experience in ENABLON L2 & L3 incidents support. The ideal candidate will handle...
Responsibilities: Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls. Author validation plans, verification reports, and decommissioning documentation. Ensure compliance ...
Job Description: The Dispensing Technician supports the manufacturing of therapeutic proteins (API) by accurately dispensing raw materials-liquids, powders, acids, and bases-under cGMP conditions. This role requires precision, compliance, ...
Responsibilities: Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures. Coordinate with laboratory personnel to define qualification requirements. Author, review and execute equipment qualif...
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...