- Penn Medicine (Philadelphia, PA)
- …execution of day-to-day operations for the department. Ensures consistent delivery of high- quality patient care and services as a trusted advisor to the department ... and innovative for patient needs. DOO ensures compliance with regulatory bodies. **Responsibilities:** Department Strategic Planning & Change Management: +… more
- Teleflex (Wyomissing, PA)
- …Experience with documentation, method optimization, and cross-functional collaboration. * Familiarity with regulatory and quality frameworks (eg, FDA 21 CFR ... method development, and medical device evaluation, ensuring compliance with protocols, quality systems, and regulatory requirements. * Prepare, optimize, and… more
- Penn Medicine (Philadelphia, PA)
- …section Performs teaching functions with residents and Medical Laboratory Science Students. Regulatory Compliance: Works with the Division's Quality Assurance ... section Assumes overall responsibility for the formulation and monitoring of a Quality Control/ Quality Improvement program Takes responsibility for staff errors… more
- Guidehouse (Mclean, VA)
- …immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing ... immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing… more
- Actalent (Maryland Heights, MO)
- …investigations and corrective actions. + Ensure analytical methods and documentation meet regulatory requirements for FDA submissions and CMC packages. + ... types, APIs, intermediates, small-molecule, and compounded pharmaceuticals. + Understanding of regulatory guidelines ( FDA , ICH) and cGMP standards. + Excellent… more
- Terumo Medical Corporation (Elkton, MD)
- …control, quality , and company regulations and national and international regulatory body requirements for medical devices. This activity includes, but is not ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- Merck (Rahway, NJ)
- …closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance ... is preferable. + GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations. Able to report any… more
- Cedars-Sinai (Beverly Hills, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities** + ... meetings. + Notifies direct supervisor about concerns regarding data quality and study conduct. + Works closely with a... and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other … more
- Sutter Health (Sacramento, CA)
- …system committed to health equity, community partnerships and innovative, high- quality patient care. Sutter's 60,500+ employees, 14,000+ physicians and advanced ... and leads an enterprise cybersecurity program that balances patient safety, regulatory compliance, and business enablement. This role requires a visionary leader… more