- Sumitomo Pharma (Helena, MT)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First"… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory ... Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage… more
- Mount Sinai Health System (New York, NY)
- …address barriers to recruitment and retention in psychiatric populations. * Ensure compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, ... will work to ensure the operational success and regulatory compliance of a growing portfolio of research studies focused...leaders and innovators; and supporting local communities by delivering high- quality care to all who need it. Through the… more
- Baylor Scott & White Health (Round Rock, TX)
- …of surveillance data. Evaluates and modifies the plan as necessary. + Ensures compliance with national standards and regulating bodies such as Joint Commission, CDC, ... OSHA, FDA , and HHS + Provides consultation to providers, staff,...of appropriate isolation procedures. + Promotes and facilitates continuous quality improvement activities to achieve a multi-disciplinary patient approach… more
- Mentor Technical Group (Juncos, PR)
- …(MTG) provides a comprehensive portfolio of technical support and solutions for the FDA regulated industry. As a world leader in life science engineering and ... technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology and medical device safety and efficacy guidelines.… more
- Sodexo (Greensboro, NC)
- …EO, hydrogen peroxide, and ozone-based systems + Calibrate and validate sterilizers in compliance with manufacturer, AAMI, and FDA standards + Maintain detailed ... role that plays a critical part in ensuring safety, compliance , and equipment uptime in healthcare environments. **What You'll...better life for all. We believe in improving the quality of life for those we serve and contributing… more
- Sumitomo Pharma (Nashville, TN)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data...Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus… more
- Veterans Affairs, Veterans Health Administration (West Palm Beach, FL)
- …(A/E) and Construction contracts to ensure the contractor is in compliance with all contractual requirements, healthcare regulations and codes, specifications and ... care program that meets current Joint Commission, Food and Drug Administration ( FDA ), College of American Pathologists (CAP), NFPA, and VA requirements, particularly… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …by maintaining the equipment to perform as designed thereby delivering a quality product. + Performs, documents, and improves procedures and Preventative Maintenance ... Activities. + Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and...to maintenance and reliability is communicated and/or documented for compliance , history, and reliability. + Strive towards continuous improvement… more
- Abbott (Sylmar, CA)
- …smooth releases. + Work with QA, regulatory, and external partners to bring high- quality , compliant software to market. Process and Compliance + Continuously ... QA, and regulatory teams to ensure our systems are fast, reliable, and compliant with FDA and ISO standards. **What You'll Work On** As a DevOps Engineer 2 working… more