- Olympus Corporation of the Americas (Center Valley, PA)
- …clinical assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these ... Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance . Performs routine assignments independently; supports and… more
- Guthrie (Sayre, PA)
- …teams. Operations & Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA , IRB, GCP, ICH). + Experience in integrating clinical ... administrative executive to collaboratively lead the strategic, operational, and compliance functions of DGF. This role is central to...or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 years of… more
- Teva Pharmaceuticals (North Wales, PA)
- …opportunity** The Manager, US Customs & Trade Compliance (CTC)will ensure compliance with Customs, FDA , USDA and other applicable government agencies, ... focus is both import and export compliance * Ensure compliance with Customs, FDA , USDA and all other government agencies * Monitor, research and respond… more
- PCI Pharma Services (Philadelphia, PA)
- …deviations, and complaints to identify patterns requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and ... and maintaining the Electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role leads the… more
- Insight Global (Philadelphia, PA)
- …including acquisition, installation, preventive maintenance, and decommissioning. - Ensure compliance with regulatory standards (eg, FDA , Joint Commission, ... systems, including diagnostic, therapeutic, and life-support equipment. -Expertise in regulatory compliance (eg, FDA , Joint Commission, NFPA, CMS). -Proficiency… more
- Fotona (Philadelphia, PA)
- …United States, in accordance with Fotona-approved protocols and guidelines. + Strictly adhere to FDA clearances and compliance . + Successful completion of 6 to 8 ... trainings per month. + Act as a key point of contact for customers and colleagues on medical inquiries, product protocols, and clinical applications. + Contribute to creating a positive internal working environment and successful business relationships between… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …ensure compliance with pharmaceutical traceability and labeling standards + Maintain FDA and DEA regulatory compliance by ensuring cleanroom integrity and ... quality checks to ensure shipment integrity, proper labeling, and compliance . + Generate and verify shipping documentation such as...Time Management + Familiarity with DEA, DSCSA, and cGMP compliance + Experience with RF technology + Experience in… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …returns adhering to company policies, procedures, and documentation requirements + Maintain FDA and DEA regulatory compliance by ensuring cleanroom integrity and ... capacity with Excel and Outlook + Pharmaceutical Regulatory statues, GMP compliance + Previous Distribution, Inventory Control, and Forklift training + Working… more
- St. Luke's University Health Network (Allentown, PA)
- …OMB A-133), NIH & NSF Grant Compliance , as well as institutional compliance programs. Knowledge of FDA regulations for clinical trials including 21 CFR ... ability to pay for health care. The Director, Research Finance and Compliance provides strategic and operational leadership for the financial management, regulatory … more
- System One (Malvern, PA)
- …review and reporting globally. + Perform duties as the main Regulatory Contact for FDA , Person Responsible for Regulatory Compliance , or "PRRC" (per EU MDR), and ... + Manage Regulatory and Medical Affairs SOPs to ensure full compliance with global regulatory requirements. + Maintain current knowledge of changes… more