- Astrix Technology (Irvine, CA)
- …System policies and procedures and applicable external requirements and standards, including FDA , ISO 13485, and other worldwide regulatory agencies pertaining ... Science + Years' Experience: 0-1 years + Familiarity with regulatory reporting requirements for medical devices (eg MDRs, Vigilance...device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803… more
- Fortive Corporation (Irvine, CA)
- …productivity. Ensure all designs and projects are compliant with GMP, FDA , ISO 13485, and applicable regulatory requirements. **Required Qualifications:** ... facility systems, and capital projects with a focus on quality, compliance , and operational excellence. **Key Responsibilities:** Design and develop mechanical… more
- Philips (Ontario, CA)
- …information for weekly and monthly safety meetings, tracking training to ensure compliance with Corporate Regulatory Task Schedule, identifying gaps in training ... areas. The role is site based in Ontario, CA - an air-conditioned FDA regulated manufacturing environment for Medical Devices and Pharmaceutical drugs (ISO 13485).… more
- Fortive Corporation (Irvine, CA)
- …the development and assessment of new technologies for potential products following the regulatory guidelines / standards ( FDA , TGA, ISO, EU MDR etc.). Ensures ... and designing and developing safe and effective company products in compliance to new product development procedures. Responsibilities: Under supervision and general… more
- AbbVie (Irvine, CA)
- …*Supplier oversight, assuring responsible Third Parties are complaint with cGMPs, regulatory and corporate compliance requirements and contractual agreements as ... material inspection through shipment of final product are in compliance with Corporate and governmental regulations. This role is...May be required to prepare and present data during regulatory audits ( FDA , EMA, Anvisa, etc) and… more
- Caldera Medical (Westlake Village, CA)
- …Corrective and Preventive Action (CAPA) activities to ensure compliance with FDA , ISO, and other applicable regulatory requirements. The ideal candidate will ... of effectiveness. * Monitor CAPA progress to ensure timely closure in compliance with internal procedures and regulatory requirements. * Collaborate with… more
- Ascendis Pharma (Palo Alto, CA)
- … Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits. . ... Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local… more
- Stryker (San Jose, CA)
- …Quality. + Work on process improvement projects while applying software industry practices, compliance standards and guidance ( FDA /HHS). + Act as a subject ... Software in a Medical Device (SiMD), supporting post-market activities to ensure compliance , drive customer quality, and address regulatory requirements, with… more
- ThermoFisher Scientific (San Francisco, CA)
- …Trend Reports required. **Knowledge,** **Skills** **and Abilities:** + Exceptional cGMP, GLP and FDA compliance knowledge. + Possess a highly developed quality, ... Metrics & Trend Reports. Develop and implement Quality Systems aligning with Regulatory and Corporate Standards. Guide team to foster quality culture, compliance… more
- Fortive Corporation (Irvine, CA)
- …improvements and operational excellence** through automation and Lean methodologies. ** Regulatory Compliance & Validation** + Ensure **Building Management ... manage priorities **for facilities and CAPEX investments** , ensuring ** compliance with regulatory standards** . + Lead...validation** for facility, automation, and process systems. + Ensure compliance with ** FDA , EMA, GMP, OSHA, and… more