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 deli...
Roles & Responsibilities: Performs work under general supervision. Provide quality, technical support and oversight during manufacturing activities. Review executed batch records and evaluate product and facility deviations;draw conclu...
Job Description: Regulatory Affairs Specialist with working knowledge of FDA, and CE marking requirements for IVD products. Client is currently transitioning from IVDD to IVDR (In Vitro Diagnostic Regulation). The RAS is responsible for ...
degree (M.S., MPH, Ph.D., or similar degree) in the health sciences, lifesciences, clinical sciences or biomedical...
Job Description: This individual will oversee an Electronic Batch Record (EBR) implementation project that began in Q4 2025. The current Project Manager will provide knowledge transfer and onboarding prior to transitioning out of the rol...
Responsibilities: The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. This role ensures adherence to local, state, and federal regul...
Summary : We are seeking an experienced Senior Supplier Quality Engineer to lead supplier quality assurance activities for external manufacturing partners within a pharmaceutical / regulated environment. Roles & Responsibilities: Lead ...
Requirements: Performs routine production functions including filling, utility operations, packing, packaging, assembling, labelling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA (Foo...
Skillset Matrix Manager Notes Technology Requirements (I.E Programs, systems, etc) Familiar with Microsoft Office, email, IMs What does a typical day look like? (daily tasks) Assembling medical devices in a cleanroom setting Preferred ba...
Job Description: Regulatory Affairs Specialist with working knowledge of FDA, and CE marking requirements for IVD products. Client is currently transitioning from IVDD to IVDR (In Vitro Diagnostic Regulation). The RAS is responsible for ...