- Cedars-Sinai (CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties & 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
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Job Duties and ... 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
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Master Record (DMR) and makes significant contributions to associated regulatory submissions. **Responsibilities** * Manage Design and Development activities for ... meet or exceed requirements and can be manufactured with the highest quality . * Manage device and combination product development projects effectively using… more
- Bausch Health (Bothell, WA)
- …Matlab. Use of defect tracking tools such as TestTrack, JIRA, etc. Knowledge of FDA Quality System and Design Control requirements and their application to ... action. Work closely with other departments to ensure projects conform to all regulatory and quality regulations. Stay up-to-date and follow all procedures… more
- Hologic (Newark, DE)
- …device innovation, dedicated to improving lives through advanced technology and rigorous quality standards. As we expand our portfolio and reach, we are looking ... strategies, policies, and processes to ensure **Hologic's** medical products meet regulatory standards and achieve necessary certifications (eg, ISO, FCC, UL, IEEE).… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …other senior managers within R&D and across the enterprise in defining regulatory strategy, developing programs to support commercial strategy, building the pipeline ... external resources. Further responsibilities including leading the clinical contribution to regulatory filings and handling information requests from regulatory … more
- BeOne Medicines (Emeryville, CA)
- …integrate regulatory feedback to strengthen enrollment practices and operational quality . + Build and maintain relationships with research sites and external ... representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to embed diversity into study… more
- Actalent (Santa Clara, CA)
- …will collaborate with cross-functional teams and play a key role in maintaining quality and regulatory excellence. Please note: This position requires onsite ... (eg, Chemistry, Biology, Nursing). + 2-3 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device or… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an exceptional rating from the National… more
- Lauridsen Group Inc. (Ankeny, IA)
- …coordinating cross-functional commercialization activities. This role bridges product development, quality assurance, regulatory compliance, and customer support ... degree. + 2-4 years of experience in food manufacturing, quality , or regulatory roles. **JOB DUTIES:** +...formulation software preferred. + Familiarity with food labeling regulations ( FDA , USDA, etc.) and quality systems. +… more
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