- Cardinal Health (Sharon Hill, PA)
- …with all regulatory standards including EHS, cGMP, Radiation Safety, applicable FDA and pharmacy laws, DOT, and internal policies and interpretations + Manages ... sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (ie FDA , NRC, DOT) to support patient treatment through disease diagnosis,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …integrity, accuracy, and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices (GCDMP). This ... Data Managers, Programmers, Biostatisticians, Clinical Operations, Medical Directors, and Regulatory staff to meet project deliverables and timelines for clinical… more
- The Hershey Company (Hershey, PA)
- …* 1.This role is responsible for all food safety, quality, and regulatory compliance of the Agile Innovation Product Development Process and traditional early-stage ... shifting business needs. *Thorough knowledge of Food Safety and HACCP, GMPs, FDA regulations, quality design principles. * FDA PCQI certification preferred.… more
- Cardinal Health (Harrisburg, PA)
- …You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team develops ... that support the Medical Device segment's Product Management, Marketing, Quality, Regulatory , and Product Design/R&D teams. Cardinal Health has deployed Oracle Agile… more
- Merck (West Point, PA)
- …ensure products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements. This position will lead ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions. + Lead the… more
- Edwards Lifesciences (Allentown, PA)
- …and other scientific documents (as appropriate). + Independently author complex regulatory responses. + Perform systematic literature reviews from initiation to ... external stakeholders (as appropriate). + Ensure documents comply with regulatory guidelines. + May travel up to 15% to...and EU MDR for clinical evaluations. + Experience with FDA PMA applications. + Strong knowledge of scientific research… more
- University of Pennsylvania (Philadelphia, PA)
- …with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures (SOPs), ... Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously....review organizations, most notably the Food and Drug Administration ( FDA ). In addition to clinical trial management, the Director… more
- University of Pennsylvania (Philadelphia, PA)
- …of study activities, including subject recruitment, data collection, regulatory documentation, and communication with internal and external collaborators. ... of research protocols. Attention to patient safety, data integrity, and regulatory compliance is essential. This position requires adherence to University of… more
- American Red Cross (Philadelphia, PA)
- …Spring Garden St. facility in Philadelphia, PA. The facility is regulated by the FDA . It is 245,000 square feet. **Experience working in an FDA -regulated, GPM ... on all HVAC equipment and other related machinery. + Ensure all regulatory operations meet the minimum compliance standards. Maintain both the ongoing regulated… more
- Penn Medicine (Philadelphia, PA)
- …self and assigned area(s) are compliant with all applicable federal, state, and local regulatory standards (ex OSHA, TJC, DOH, FDA , HIPAA, etc.) + Oversees the ... Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA,...and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and… more