- 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
- Biomat USA, Inc. (Fairless Hills, PA)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… 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
- Kedplasma (Pittston, PA)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on...scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
- Envista Holdings Corporation (Quakertown, PA)
- …Engineering, Operations, and Purchasing/Procurement to ensure product quality and compliance requirements are met with on-going production demands. The position ... products comply with the US Food and Drug Administration ( FDA ), local and state agencies and global health authority...+ Execute process improvements as they relate to QMS compliance with ISO/GMP requirements + Identify and drive Corrective… 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 ... Regulatory Affairs, Research & Development, Legal, and Health Care Compliance . **Job Duties** + Candidate with Bilingual skills -...and experience working with: + Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820) + Various… 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 protocols. Attention to patient safety, data integrity, and regulatory compliance is essential. This position requires adherence to University of… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …Certified Laboratory Equipment Specialist (CLES), or Certified Healthcare Technology Manager (CHTM). Continuous maintenance of certification is not required ... and ensure the data are correctly entered into the CMMS. Ensure compliance with all applicable standards, policies, procedures, and regulatory requirements such as… more
- Bayer (Philadelphia, PA)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... compliance guidelines for all external contacts; + Prepares and...and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as… 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 ... will drive cross-functional initiatives to enhance product safety, regulatory compliance , and customer experience through advanced data analytics, digital tools,… more