- UNC Health Care (Lenoir, NC)
- …judgment and coordinates and supervises the activities to maintain FDA /ACR requirements. **Responsibilities** : + Performs quality radiographs on patients ... supervises all quality control tests to meet ACR and FDA requirements for digital mammography. + Ensures all quality...completed within the required parameters of the ACR and FDA . + Uses appropriate device to measure viewbox intensity.… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP BRH ... operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient,...comply with relevant Life Sciences industry regulations, including GxP, FDA , EMA, and other regulatory bodies. + Lead the… more
- IQVIA (Durham, NC)
- …expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use of Patient ... development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED +...regulatory practices, expectations and engagements outside of the US FDA and EMA In addition, take on other leadership… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... Excellent understanding of the clinical research process, including US FDA , EU, and GCP regulations, and the function of...Excellent understanding of the clinical research process, including US FDA , EU, and GCP regulations, and the function of… more
- Fujifilm (Raleigh, NC)
- …on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide ... to HLUS and its subsidiary companies on substantive legal topics, including FDA marketing and advertising regulations and other regulations specific to Life… more
- Biomat USA, Inc. (Greenville, NC)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- US Tech Solutions (Wilson, NC)
- …within the biological and/or pharmaceutical industry + Knowledgeable of FDA /EMEA regulatory requirements applicable to biologics and/or pharmaceuticals and ability ... to apply GMP regulations and other FDA and international guidelines to all aspects of the...+ Pharma background, helpful + Must have knowledge of FDA / EMEA regulatory documentation **Education:** + Bachelor's degree… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …Typically requires oversight from a more senior level engineer + ISO compliance, FDA 21 CFR 820 compliance, and cGMP efforts - Understands and has knowledge ... of FDA and ISO regulations and cGMP. Requires oversight from...knowledge and understanding of the Food and Drug Administration ( FDA ) 21 CFR 820 and International Organization for Standardization… more
- Stryker (Durham, NC)
- …Health & Safety role responsibilities:** + Ensure compliance with OSHA, EPA, FDA , ISO 13485, and company-specific EHS standards. + Develop, implement, and maintain ... facility layouts. + Ensure engineering activities comply with applicable regulations, including FDA 21 CFR Part 820 and ISO 13485. **What you need:** **Required:**… more
- Reckitt (Wilson, NC)
- …/ utility operations. + Serve as automation SME and ensure compliance with GxP, FDA , EU Annex 11, and 21 CFR Part 11 requirements. + Validate and maintain ... technologies for performance optimization. + Drive regulatory alignment (GMP, FDA , ISO, EHS) across automation activities and support audits, validation,… more