- Jabil (West Chester, PA)
- …globe. Are you experienced in Regulatory Compliance ? Jabil is seeking a qualified Regulatory Compliance Manager to work in West Chester, PA. As the ... Regulatory Compliance Manager , you will...Regulatory Compliance Manager , you will manage all ...audits: eg Notified Body, Ministry of Health country inspections, FDA , J&J Corporate Audits for site. + Audit preparation… more
- Sumitomo Pharma (Harrisburg, PA)
- …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performing routine ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase 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 … more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- Quality Compliance Manager Department: Quality Location: Allentown, PA START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3446854&source=3446854-CJB-0) About the Job The Quality Compliance Manager is responsible for overall … more
- Teva Pharmaceuticals (North Wales, PA)
- Manager , US Customs & Trade Compliance Date:...US Customs & Trade Compliance (CTC)will ensure compliance with Customs, FDA , USDA and other applicable ... Protection Agency, Federal Communications Commission, Fish & Wildlife, Nuclear Regulatory Commission, Office of Foreign Assets Control et al....both import and export compliance * Ensure compliance with Customs, FDA , USDA and all… more
- Philips (Pittsburgh, PA)
- **554497 Trade Compliance Manager ** You are a part of a team that is at the core of ensuring that we meet Philips' promise to comply with trade and ... + Review inbound and outbound shipping to ensure import/export compliance , to include export licenses, duty drawback, FDA...EPA, duty savings. + At the direction of the manager /lead take on day-to-day projects of varying scope and… more