- Cordis (Irvine, CA)
- …of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical ... for risk mitigation to ensure the safety and efficacy of medical devices. + Regulatory Compliance: Stay up to date with regulatory requirements, standards, and… more
- Sutter Health (Antioch, CA)
- …adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Exercises sound judgment and has developed clinical skills to ... billing, pricing, record keeping, and provision of services required to meet regulatory requirements. + Maintains records of drug distribution, works with vendors to… more
- Sumitomo Pharma (Sacramento, CA)
- …and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- ThermoFisher Scientific (San Francisco, CA)
- …Metrics & Trend Reports. Develop and implement Quality Systems aligning with Regulatory and Corporate Standards. Guide team to foster quality culture, compliance, ... trends and have action plans in place to address them. + Support Regulatory Inspections, Corporate Audits, and Client Audits specific to the functions within the… more
- Sumitomo Pharma (Sacramento, CA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- BeOne Medicines (Emeryville, CA)
- …implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines, tracking and budgeting. ... and non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program management,… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Key Responsibilities:** + Coordinates data ... Excellent written and verbal communication skills. + Ability to strictly adhere to regulatory requirements and ethical guidelines. This role is designed to be 100%… more
- Abbott (San Diego, CA)
- …implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. **Required Qualifications:** + Bachelor's ... Abbott is a global healthcare leader that helps people live more fully...cross-functional partners such as Quality Assurance, Operations, Marketing and Regulatory Affairs. + Strong technical, negotiating, decision-making and analytical… more
- J&J Family of Companies (Santa Clara, CA)
- At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, ... we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact… more
- Abbott (Temecula, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Abbott is a global healthcare leader that helps people live more fully...Our portfolio of life-changing technologies spans the spectrum of healthcare , with leading businesses and products in diagnostics, medical… more