- Cook Medical (Pittsburgh, PA)
- …methodology associated with manufacturing a cell therapy product in an FDA -regulated environment.* Experience in Quality Assurance and/or Compliance functions ... helping others, and driven by integrity, we invite you to apply. The Manager , Investigations, CAPA and Complaints at Cook MyoSite, Inc. is responsible for overseeing… more
- West Pharmaceutical Services (Williamsport, PA)
- Value Stream Change Manager Requisition ID: 70987 Date: Aug 7, 2025 Location: Williamsport, Pennsylvania, US Department: Operations Description: At West, we're a ... protecting Operational delivery requirements. Reports directly to the Operations Manager . Coordinates and directs Change-dedicated resources as required. **Essential… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …alignment of technical activities with regulatory strategies. + Utilizes scientific training when interfacing with Management of technical areas and project teams ... teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, &… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents...initiates new or special assignments with occasional direction from Manager . Must have ability to work in a team… more
- Globus Medical, Inc. (Audubon, PA)
- …both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- Globus Medical, Inc. (Audubon, PA)
- …both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- Globus Medical, Inc. (Audubon, PA)
- …both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- CSL Plasma (Philadelphia, PA)
- …as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company ... facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for deficiencies.… more
- Biomat USA, Inc. (Fairless Hills, PA)
- … + Assists in the control of center donor funds as determined by the Center Manager + Participates in the onboarding, training , and cross- training of staff ... daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts… more
- University of Pennsylvania (Philadelphia, PA)
- …in study team meetings, research team meetings, and ongoing protocol training / compliance meetings. The Regulatory Affairs Specialist-CC is expected to ... I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and… more