- Mentor Technical Group (PR)
- …in SOP writing or quality documentation. + Knowledge of regulations such as FDA 21 CFR Part 11, ISO 13485, ICH Q10, and GxP principles. + Proficiency in ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- University of Pennsylvania (Philadelphia, PA)
- …maintenance and data entry + Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the protocol and ... research nurses, and staff at Penn and partner institutions to ensure high- quality execution of research protocols. Attention to patient safety, data integrity, and… more
- J&J Family of Companies (Athens, GA)
- …protocols. + Generate and maintain validation documentation, including final reports ensuring compliance with GMP, FDA , and industry standards. + Work closely ... with engineering, quality , and operations teams to troubleshoot validation challenges and...inspections by providing validation documentation and justifications. + Ensure compliance with cGMP, 21 CFR Part 11, ISPE Baseline… more
- SUNY Upstate Medical University (Syracuse, NY)
- …role will also provide ongoing education and mentorship to CRAs to ensure compliance with Good Clinical Practice (GCP), FDA regulations, and sponsor expectations ... and budgets with sponsors, CROs, and research departments, ensure compliance with institutional policies, federal regulations, and sponsor requirements, collaborate… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …bring new and modified medical devices to market and ensure ongoing compliance . They participate on cross-functional teams, lead the development of global regulatory ... in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other regulatory documents for submission to… more
- Cedars-Sinai (Los Angeles, CA)
- …collaborates with bioinformatics to develop and maintain trial management systems. Ensures compliance with all federal and local agencies, including the Food and ... Drug Administration ( FDA ) and local Institutional Review Board. Primary Duties and...and presenting findings to support study objectives and data quality initiatives. + Identifies and resolves operational/data problems, recommending… more
- GE HealthCare (Troy, NY)
- …and regulations as they apply to this job type/position + Complete all planned Quality & Compliance training within the defined deadlines + Identify and report ... any quality or compliance concerns and take immediate...and draw conclusions accordingly + Familiarity and experience with Quality Management Systems in an FDA regulated… more
- US Foods (Rosemont, IL)
- …will participate in the development and implementation of various food safety and quality policies and procedures to ensure compliance with regulatory, legal, ... The role will provide technical support for food safety, quality and regulatory compliance to all company...Proficient in Microsoft Office suite. + Demonstrated knowledge with FDA , including the new Food Safety Modernization Act &… more
- Hologic (Newark, DE)
- …Device Quality Assurance:** Provide comprehensive support to ensure the quality , compliance , and safety of medical devices throughout their lifecycle, ... projects (eg, internalizations, supplier changes, value improvement projects), while maintaining quality , compliance , and safety. + ** Quality Assurance… more
- Danaher Corporation (New Port Richey, FL)
- …(https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory Compliance JOB SUMMARY ... material science fields with 15 years of progressive Regulatory compliance and / or quality assurance experience....AS9100 / CAA Part 145/CAA Part 21 standards. GMP, FDA knowledge and other ISO standards an advantage. +… more