- Northern Light Health (Bangor, ME)
- …letters are reviewed for accuracy and sent out for all mammographic exams within the FDA mandated time frame. The must be able to be resourceful when information on ... provided for patients covered in that CDC program. Complies with all FDA regulations regarding breast imaging records and storage. Will read every radiologist… more
- Abbott (Casa Grande, AZ)
- …of millions worldwide. You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. **What You'll Work On** + ... procedures. **You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures.** **Required Qualifications** +… more
- Eurofins US Network (San Jose, CA)
- …validate, and maintain EO sterilization processes in compliance with ISO 11135, FDA , EPA, and other applicable standards. + Support new product development through ... knowledge of EO sterilization regulations and standards, including ISO 11135, cGMP, FDA , and EPA NESHAP. + Experience with validation, quality assurance, document… more
- Candela Corporation (Marlborough, MA)
- …HASS and other reliability test methods. *Knowledge of design requirements to meet FDA & IEC 60601-1 Medical safety and EMC approvals. Work directly with safety ... * Experience working on Medical Devices or regulated environments *Working knowledge of FDA , IEC and UL standards relating to medical devices * Capable of executing… more
- Actalent (Los Angeles, CA)
- …source documents to ensure that research is being conducted according to IRB, FDA , OHRP, HIPAA and other agency guidelines. * Maintains high quality, up-to-date ... regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies. * Completes appropriate IRB… more
- BD (Becton, Dickinson and Company) (El Paso, TX)
- …product complaint process, ensuring compliance with global regulations (such as FDA cGMP and ISO standards), leading, trending, escalating and approving customer ... and ensuring timely submission to appropriate regulatory agencies like the FDA . + **Documentation and Record Keeping:** Ensuring accurate and detailed records… more
- CBRE (Frederick, CO)
- …cGMP (current Good Manufacturing Practice) regulations, Good Documentation Practices (GDP), FDA , and other regulatory agency guidelines, as well as Company Standard ... cGMP, Good Documentation Practices (GDP), and general regulatory requirements (eg, FDA ) is preferred. + Experience with a Computerized Maintenance Management System… more
- Billings Clinic (Bozeman, MT)
- …or fellows. + Assists in maintaining accreditation readiness (CAP, CLIA, FDA , TJC). + Oversees QA/QC processes including documentation, monitoring, and proficiency ... supervision). + Strong understanding and application of CAP, CLIA, TJC, and FDA standards. + Proficiency in laboratory Quality Assurance/Quality Control systems. +… more
- Hologic (Louisville, CO)
- …+ Familiarity with regulatory standards for medical device development (eg, FDA , IEC 60601-1). **Clinical & Application Knowledge:** + Strong clinical and ... experience with a PhD. + Experience developing medical devices compliant with FDA and IEC 60601-1 standards is highly desirable. **Behavioral Competencies** +… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. + ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more