- Olympus Corporation of the Americas (Center Valley, PA)
- …assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas ... team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance . Performs routine assignments independently;...your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes **Additional ... responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA … more
- BioLife Plasma Services (Camp Hill, PA)
- …+ Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA -regulated environment. + Effective communication, ... performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... 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)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... 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
- University of Pennsylvania (Philadelphia, PA)
- …closeout visits with sponsors and/or CROs. + Show vigilance in patient safety, protocol compliance , and data quality . + Adhere to all University of Pennsylvania, ... studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical research performed.… more
- Biomat USA, Inc. (Fairless Hills, PA)
- …the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations ... daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and … more
- Biomat USA, Inc. (Reading, PA)
- …employees and supervise donor flow. * Learn and maintain thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration ... ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… 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 ... across Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care … more
- University of Pennsylvania (Philadelphia, PA)
- …maintenance and data entry + Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the protocol and ... research nurses, and staff at Penn and partner institutions to ensure high- quality execution of research protocols. Attention to patient safety, data integrity, and… more