- Globus Medical, Inc. (Audubon, PA)
- …Supports product development efforts from launch through commercialization, defining market requirements for our product lines. Manages products in several stages of ... development (ie existing portfolio, near-term launch, pending FDA approval and new products). Supports product lifecycle management, product roadmap, technique, new… more
- Sysco (Harmony, PA)
- …Complies with local, state and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **QUALIFICATIONS** **Education** + High school diploma or general ... individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skill and/or ability required.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …papers, and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ... ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas...initiates new or special assignments with occasional direction from Manager . Must have ability to work in a team… more
- 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...skills, and education as they directly relate to the requirements of the position, and in alignment with salary… 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
- 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...skills, and education as they directly relate to the requirements of the position, and in alignment with salary… 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
- CSL Plasma (Philadelphia, PA)
- **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance ... with CSL Operating Procedures, as well as all applicable local, state, federal requirements . This role will ensure compliance to training needs, SOPs, processes and… 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