- University of Colorado (Aurora, CO)
- …electronic data capture systems (eg EMR or EHR and data management systems ) + Clinical research regulatory experience **Knowledge, Skills, and Abilities:** + ... start up, implementation and close out functions + Develop, review, maintain regulatory and other project documentation + Coordinate site visits and other meetings… more
- Astellas Pharma (Sanford, NC)
- …+ Review and approve Product Specification documents to ensure alignment with regulatory and internal requirements. **Quality Systems and Compliance:** + Lead ... approve associated protocols, reports, and deviations to ensure compliance with regulatory and internal standards. **Technical Leadership and Support:** + Serve as… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …Baltimore/Sparks reagent plants. + Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies. ... This position is responsible for applying/interpreting the applicable Quality Systems , developing/implementing the Standard Operating Procedures and policy's for an… more
- Billings Clinic (Billings, MT)
- …benefits, obtaining and documenting informed consent in accordance with ethical and regulatory standards. * Coordinates information and documentation systems and ... human participants by performing a wide range of clinical, regulatory , and administrative responsibilities. Works collaboratively with participants, staff, and… more
- Fresenius Medical Center (Hempstead, NY)
- …+ Facilitates program and annual regulatory review audits + Collaborates with Regulatory to identify and recommend systems and practices that would improve ... to improve the overall patient experience in alignment with established quality and regulatory standards The rate of pay for this position will depend on the… more
- Actalent (Durham, NC)
- …and other regulatory requirements. + Stay current on industry and regulatory laboratory trends, adapting quality systems and practices as necessary. + ... bioseparations, and mass spectrometry characterization. + Provide technical and regulatory expertise for biologics method establishment and testing strategies. +… more
- Novant Health (Winston Salem, NC)
- …+ Strong understanding of healthcare financial operations, supply chain processes, and regulatory requirements. + Experience with ERP systems such as Infor, ... Health organization, ensuring timely and accurate payments to vendors, compliance with regulatory standards, and effective internal controls. This role leads a team… more
- SMBC (Jersey City, NJ)
- …managing large-scale programs focused on implementation of processes, methodologies, and systems that meet regulatory requirements and industry best practices. ... gap assessments against data policies and standards and reporting (management or regulatory ) requirements to identify gaps and determine remediation plans + Partner… more
- Astrix Technology (Stafford, TX)
- …and consultants. + Ensure full compliance with design control standards, quality systems , and applicable regulatory requirements (eg, ISO 10993, MDR/MDD). ... initiatives across product development, method validation, risk assessment, and regulatory compliance. **Key Responsibilities:** + Lead the design and execution… more
- Hologic (Newark, DE)
- …that improve lives globally.. **Knowledge** + In-depth understanding of quality management systems (QMS) and regulatory standards (eg, GMP, GLP, ISO, FDA, ... and maintaining quality assurance protocols that meet internal and external regulatory standards for worldwide distribution. In this role, you'll collaborate with… more
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