- BD (Becton, Dickinson and Company) (Irvine, CA)
- **Job Description Summary** Fulfill FDA , ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to ... Reporting (MDR) + Prepare and submit MDR reports to FDA + Identify problems and lead projects to improve...assigned by Leadership (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is… more
- Abbott (Alameda, CA)
- …Import & Export, you will provide subject matter expertise to ensure site compliance with all relevant customs regulations and trade laws and regulations, including ... 19CFR, FDA , and other US regulatory agency requirements. This is...process and develop effective internal controls to ensure site compliance with corporate and regulatory requirements. + Develop and… more
- Abbott (Alameda, CA)
- …Our 114,000 colleagues serve people in more than 160 countries. **Sr. Quality Compliance Specialist** **Working at Abbott** At Abbott, you can do work that matters, ... executives, and scientists. **The Opportunity** We are seeking a detail-oriented and proactive Compliance Specialist to join our Compliance team. This role is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations + Analyze trends ... Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions + Collaborate with...to the conduct of clinical trials and guidelines (eg, FDA , EMA, ICH) and related industry standards and trends… more
- Cardinal Health (Sacramento, CA)
- …- Classification will collaborate with multiple teams and departments to ensure compliance and optimize trade operations. Cross training will be required to provide ... and special program eligibility assessments, including documentation review and compliance verification. + Collaborate with sourcing, procurement, engineering, and… more
- United Therapeutics (Sacramento, CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... about pharmacovigilance! You are a team player who loves quality, compliance , finding solutions and ensuring training standards are implemented and successful.… more
- Abbott (Santa Clara, CA)
- …requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory activities and ... regulations and experience such as from the Food and Drug Administration ( FDA ) Center for Devices and Radiological Health (CDRH). This Senior Manager Regulatory… 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 ... facilities as needed. **What you will do:** + Collaboratively ensure compliance with Quality Management System requirements for post-market activities, driving… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Compliance & Risk Management: Ensure all legal technology solutions align with global compliance frameworks (eg, GDPR, FDA , EMA) and company policies. + Team ... driving the strategic implementation of legal technology solutions to enhance efficiency, compliance , and cost management within the legal department. As a senior… more
- Edwards Lifesciences (San Diego, CA)
- …Stay current with training and ensure all activities align with ACCME, OIG, and FDA guidelines, as well as Global Compliance policies. + Contribute to Continuous ... educational grant applications and prepare documentation for review meetings. + Ensure Compliance & Documentation: Collect and verify Proof of Performance and budget… more