- 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, requiring working knowledge of products under review...Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- University of Pennsylvania (Philadelphia, PA)
- …and research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop solutions. Implement ... + Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the...the conduct of study audits by sponsors, CRO's, the FDA and other entities as required. + Participate in… more
- Biomat USA, 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
- 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
- University of Pennsylvania (Philadelphia, PA)
- …Reporting to the Regulatory Affairs New Study & Continuing Review Manager , the Senior Regulatory Affairs Start-Up Specialist will independently prepare and ... oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees. In collaboration… more
- BD (Becton, Dickinson and Company) (Zelienople, PA)
- **Job Description Summary** Under the supervision of the Manufacturing Engineering Manager , the Manufacturing Engineer is responsible for supporting manufacturing by ... us. **Position Summary:** Under the supervision of the Manufacturing Engineering Manager , the Manufacturing Engineer is responsible for supporting manufacturing by… more
- Penn Medicine (Philadelphia, PA)
- …Full Time Summary: The Certified Nursing Assistant (CNA) assists the practice manager and physicians in maintaining a patient/customer focus, supports the delivery ... state, and local regulatory standards (ex OSHA, TJC, DOH, FDA , HIPAA, etc.) + Oversees the POCT process to...information back up to management. + Effectively works with manager and providers to establish, implement, and maintain practice… more
- Globus Medical, Inc. (Eagleville, PA)
- …to, supervising all operators and engineers. This individual works with the site manager and all engineers and operators to ensure the manufacture of high-quality ... compliance within company policies and procedures (eg, compliance with FDA , ISO 13485, or other regulations). + Complies with...+ Demonstrated knowledge of ISO and quality systems as FDA and OSHA requirements, as a plus + Experience… more
- Penn Medicine (King Of Prussia, PA)
- …Are you living your life's work? Summary: + Accountable for tracking of all FDA regulated infusion devices (pumps), as well as non- FDA regulated equipment, used ... ancillary supply list, to establish a patient specific account within CPR+ Equip manager . Maintains all records, and a schedule of serial biomedical inspection and… more