- Olympus Corporation of the Americas (Center Valley, PA)
- …effective processes using advanced data analytics to drive digitalization and process simplification while ensuring sustained compliance. + Identify priorities and ... understanding and working knowledge of appropriate global regulations and standards including FDA Quality System Regulations and ISO 13485:2016 + Strength in people… more
- Fujifilm (Harrisburg, PA)
- …always prepared to promote and provide reference for our solution, and that the process for utilizing is well defined and organized. + Collaborates closely with MI ... with marketing communications and sales leadership. + Work collaboratively with training manager to ensure all level of sales are prepared to effectively execute… more
- Fujifilm (Harrisburg, PA)
- …opinion leaders in the Endoscopy space. The role of the Business Development Manager is to understand and define our internal and external endoscopic customers' ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …+ Facilitates MES (Camstar) / ERP (Epicor) validation activities in an IS0-13485/ FDA regulated environment. + Supports product and process change implementation ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- West Pharmaceutical Services (Exton, PA)
- …Stories. + Provide system support and maintenance in alignment with standards and process set within the ERP Services Delivery model, West policies and procedures as ... Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. + Create and maintain system lifecycle documents...+ Work within and participates in the Change Control process . + Conform with and abide by all regulations,… more
- GE HealthCare (State College, PA)
- …- while also supporting manufacturing teams with real-time troubleshooting and process improvements. This position reports to the Engineering Infrastructure ... Manager . **Job Description** **Roles and Responsibilities** + Configure, maintain,...production workflows. + Ensure compliance with regulatory standards (eg, FDA , ISO) in system usage and documentation. + Support… more
- Penn Medicine (Philadelphia, PA)
- …procedures. Communicates with patients regarding patient flow and wait times - keeps manager aware of potential issues as they arise. Issues referrals and obtains ... charges. Orders supplies for the office and generates front-end process reports as requested. + Other / Regulatory: Ensures...federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and… more
- Penn Medicine (Bala Cynwyd, PA)
- …+ Communicate with patients about flow and wait times, keeping the manager informed of potential issues. + Issue referrals and obtain pre-authorizations as ... missing charges. + Order office supplies and generate front-end process reports as requested. Other / Regulatory: + Ensure...federal, state, and local regulatory standards (eg, TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME). + Be flexible… more
- University of Pennsylvania (Philadelphia, PA)
- …(PI), study team and Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research nurses (CRNs). The CRC ... independent central review of clinical trial end-points (eg, imaging data). Transport, process and ship biological materials (eg, blood, urine, tissue, etc.) using… more
- University of Pennsylvania (Philadelphia, PA)
- …and report study data. Complete case report forms and resolve data queries. Process and ship study specimens including blood and urine. Participate in initiation, ... and data qualify. Adhere to all University of Pennsylvania, FDA and GCP guidelines. The Clinical Research Coordinator C...duties above with more limited supervision from the project manager . In addition, will develop complex documents such as… more