- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- University of Pennsylvania (Philadelphia, PA)
- …studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical research performed. ... policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research...the conduct of audits by study sponsors, CROs, the FDA , and other entities as required. + Process and… more
- Grifols Shared Services North America, Inc (Williamsport, PA)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Biomat USA, Inc. (Fairless Hills, PA)
- …of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary ... Responsibilities** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma… more
- West Pharmaceutical Services (Exton, PA)
- …expectations are met through effective reporting and communication. + Assist the QA Manager by ensuring WSS team members are trained in GMP-relevant topics and ... ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations. **Education** + Bachelor's Degree and/or Masters in Science Technology… more
- University of Pennsylvania (Philadelphia, PA)
- …I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and ... process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews,… more
- Kedplasma (Pittston, PA)
- …suitability and handling donor reactions under the direction of the Center Manager , Physician Substitute Supervisor and Center Medical Director. Operates within the ... scope of EU Guidance on Good Manufacturing Practices and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...and meeting(s) in a timely manner as instructed by supervisor/ manager . + Cooperate with department personnel, as well as… more
- Kedplasma (Pittston, PA)
- …Responsible for registering and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on Good Manufacturing Practice ... and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...and meeting(s) in a timely manner as instructed by supervisor/ manager . + Cooperate with department personnel, as well as… more
- Fujifilm (Harrisburg, PA)
- …the assistance of technical support, as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Envista Holdings Corporation (Quakertown, PA)
- …that the company's products comply with the US Food and Drug Administration ( FDA ), local and state agencies and global health authority and agency regulations. + ... as a resource for Production Part Approval Process (PPAP). + Support the QA Manager in any assigned activity and perform other duties as assigned . **Job… more