- Sanofi Group (Morristown, NJ)
- …and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion ... promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable. + Provides US RA AdPromo strategic guidance and… more
- Abbott (Alameda, CA)
- …oversees the design, development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in ... activities under guidance and mentoring junior engineers. Adherence to FDA -compliant Design Control procedures and proficiency in software implementation are… more
- US Tech Solutions (North Chicago, IL)
- … Assurance (PMQA) Analyst I will investigate and maintain **complaint files,** in compliance with regulations established by the FDA and international regulatory ... bodies, and submit safety reports to the FDA and international Competent Authorities. + In addition will...+ The candidate must conduct their work activities in compliance with all internal requirements and with all applicable… more
- CBRE (Jeffersonville, IN)
- …those respective contract terms. **ESSENTIAL DUTIES AND RESPONSIBILITIES** Oversees the day-to-day Quality and Compliance Team operations at one account sites ... as defined in the master service agreement (MSA) or Quality Agreement. Executes the CBRE compliance program...preferred. Previous supervisory experience a plus. **CERTIFICATES and/or LICENSES** FDA , ISO, or similar quality assurance audit… more
- Endo International (Rochester, MI)
- …work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to ... test method, validation protocol, or validation report) for completeness and compliance when necessary + Reviews and evaluates drug substance supplier's technical… more
- HonorHealth (AZ)
- …Summary Coordinates all activities related to the Institutional Review Board and assures compliance with IRB guidelines and FDA regulations. In accordance with ... 3,700 affiliated providers and close to 2,000 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional… more
- Stryker (Portage, MI)
- …Divisional Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, ensuring quality issues are addressed effectively and in compliance with ... (NCs) and Corrective and Preventive Actions (CAPAs) for completeness, accuracy, and compliance with FDA , ISO 13485, and global regulatory standards. +… more
- BPC Plasma, Inc. (Fort Myers, FL)
- …for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance , and achievement of production goals. This role provides direct ... with operational management of a Plasma Collection Center, ensuring compliance with all applicable policies and regulations and overall...Manager is not present. + Collaborates with Training and Quality staff to ensure that training and quality… more
- ABM Industries (Carlsbad, CA)
- …policies. + Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory ... as well as internal and regulatory audits. + Ensure compliance with all Facilities and Quality System...Remain knowledgeable of current federal and international regulations, including FDA 21CFR part 820, FDA 21CFR part… more
- Terumo Medical Corporation (Elkton, MD)
- …coordinating all activities from development to full-scale production in in compliance with TMC Quality System requirements and regulatory standards. ... 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