- BD (Becton, Dickinson and Company) (San Diego, CA)
- …frameworks, Agile SDLC, experience with cross functional team transactions, and various FDA SW related guidance's and industry best practices. The role involves ... more
- BeiGene (San Mateo, CA)
- …The individual will have extensive experience with the United States FDA , oncology division, leading key interactions including supporting advisory committee (ODAC) ... more
- Houston Methodist (Houston, TX)
- …Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on ... more
- Hy-Vee Food Stores (West Des Moines, IA)
- …produced at Hy-Vee food-manufacturing facilities comply with applicable USDA and FDA food labeling regulations. Reporting Relations: Accountable and Reports to: ... more
- Actalent (Holly Hill, FL)
- …to employees, identify skill gaps, and recommend training opportunities. 3. Compliance with FDA Regulations, GMP & SOPs * Ensure all activities align with FDA ... more
- Alaka'ina Foundation Family of Companies (Fort Detrick, MD)
- …and records associated with nonclinical studies, to include those conducted under FDA Good Laboratory Practice (GLP) requirements. + Perform quality review of ... more
- University of Michigan (Ann Arbor, MI)
- …agencies as appropriate to the Department of Pathology (eg, New York, California, FDA , etc.) + Suggests and helps implement training with regards to educating ... more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... more
- System One (Littleton, CO)
- …of experience in Quality Assurance and/or Regulatory Affairs, with a focus on US FDA Class II or Class III medical devices. The role requires expertise in applying ... more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …our team and lead clinical studies focused on cardiac biomarkers in an FDA -regulated environment. Job Description: We are seeking an experienced and highly motivated ... more
- Fresenius Medical Center (Waltham, MA)
- …in the interpretation and application of appropriate regulations. Responds to FDA or district office requests. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** Manage the ... more
- UNC Health Care (Lenoir, NC)
- …judgment and coordinates and supervises the activities to maintain FDA /ACR requirements. **Responsibilities** : + Performs quality radiographs on patients ... more
- Boehringer Ingelheim (St. Joseph, MO)
- …for assuring compliance of validated systems, process, equipment to current cGMP, FDA , EU, USDA, BIAH and BI corporate requirements. This includes, but is ... more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …interface with internal, external, customer and regulatory (USDA and/or FDA where applicable) inspectors regarding sanitation related non-conformance reports and ... more
- Houston Methodist (Houston, TX)
- …in a highly regulated radiopharmaceutical drug manufacturing facility in compliance with FDA cGMP guidance. * Capability to lift 50 pounds; **PEOPLE ESSENTIAL ... more
- The Boeing Company (North Charleston, SC)
- …will receive specialized training to act as a Delegate (proxy) for the FDA in performing FDA airplane certification inspections. **Position Responsibilities** + ... more
- Abbott (Burlington, MA)
- …for supporting product development from concept through sustained manufacturing of FDA regulated products. In this role, extensive experience with product ... more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …and regions. _Job Summary:_ Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation ... more
- Dana-Farber Cancer Institute (Boston, MA)
- …Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate ... more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …networks. In this role, you will have primary RA responsibility for multiple FDA Class II products, working within a collaborative team environment that fosters ... more
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