- Oracle (Little Rock, AR)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more
- Cedars-Sinai (Los Angeles, CA)
- …study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Aerotek (Smyrna, TN)
- …proficiency in MS Office. + Preferred 5 years of related manufacturing experience in an FDA facility, with an average of 3 years in a non- FDA facility. + ... packaging, especially from the food and beverage industry, are preferred due to the FDA -regulated nature of the facility. **Job Type & Location** This is a Contract… more
- Hologic (Newark, DE)
- …Standardize and enforce policies, procedures, and best practices in alignment with FDA , ISO, and internal requirements. + **Talent Management:** Recruit, train, and ... project management, communication, and interpersonal skills. + In-depth knowledge of FDA Quality System Regulation (Design Control), ISO 13485, ISO 14971, risk… more
- Actalent (Albany, NY)
- …repairs, equipment calibration, and validation support. + Ensure strict compliance with FDA regulations, cGMP, and USP 797/800 guidelines in all facility and ... with equipment qualification and validation processes. + Strong understanding of FDA regulatory requirements and industry standards. + Excellent project management… more
- United Therapeutics (Christiansburg, VA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Participate in regulatory activities such as IACUC, USDA, FDA , and AAALAC with direction from the Attending Veterinarian...perform abdominal and general surgery + Understanding of US FDA CFR for Xenotransplantation products for human use +… more
- Caris Life Sciences (Tempe, AZ)
- …Collaborate with Regulatory Affairs to prepare and review regulatory submissions (eg, FDA 510(k), PMA, EUA, IVDR), including pre- and post-market documents. + ... submission documents. + Ensure compliance with applicable regulations including FDA 21 CFR Part 820, ISO 13485, IVDR, and...within Quality Management Systems (QMS) aligned with ISO 13485, FDA QSR, or IVDR. + Experience with IVD or… more
- University of Utah (Salt Lake City, UT)
- …national and international research consortia. 5. Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research ... and compliance of all involved. The incumbent functions independently under minimal supervision, following FDA , Good Clinical Practice, IRB , NIH , NCI , NSF and/or… more
- Compass Group, North America (Escondido, CA)
- …is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. ... and all other prerequisite food safety standards are met according to USDA, FDA , FSIS, FSMA and corporate requirements. + Must have extensive knowledge of the… more
- Community Health Systems (Laporte, IN)
- …maintaining compliance with state, federal, and regulatory standards, including FDA /MQSA and ACR requirements. **Essential Functions** + Performs mammography imaging ... and maintenance, performing routine quality control testing per ACR and FDA /MQSA requirements. + Reviews physician orders and patient history, ensuring all… more