- Abbott (Alameda, CA)
- …or quality-related field. + 5+ years of experience in quality assurance or regulatory compliance in the medical device industry. + Strong knowledge of ... critical in maintaining a state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and… more
- 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 ... applicable regulatory bodies. **Job Description** We are **the makers of...Reporting (MDR) + Prepare and submit MDR reports to FDA + Identify problems and lead projects to improve… more
- Abbott (Alameda, CA)
- …and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory , corporate and divisional requirements. + Review quality ... the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA , QSR, ISO guidelines, including 21 CFR Part 11 and… more
- Abbott (Alameda, CA)
- … with all relevant customs regulations and trade laws and regulations, including 19CFR, FDA , and other US regulatory agency requirements. This is an onsite ... enhance import/export process and develop effective internal controls to ensure site compliance with corporate and regulatory requirements. + Develop and… more
- Cedars-Sinai (Beverly Hills, CA)
- …care delivery, collaborating with other healthcare team members. + ** Regulatory Compliance :** Utilize knowledge of regulating agencies ( FDA , USP, TJC, DEA, ... etc.), best practice standards, and institutional policies and procedures to maintain regulatory compliance . + **Education and Training:** Participate in the… more
- Actalent (Vista, CA)
- …+ File Vigilance Reports or Medical Device Reports to Competent Authority or FDA . + Review regulatory submissions and assign signature for approval. + ... The QA Specialist is primarily responsible for overseeing the quality and regulatory aspects of the company. This includes the development and maintenance of… 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 ... + Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions + Collaborate with the audit, inspection and CAPA… more
- Lilly (San Diego, CA)
- …as regulatory strategy development + Monitor patient safety and ensure compliance with GCP, FDA , ICH guidelines, and company policies **Cross-Functional ... Regulatory & Medical Affairs Support** + Partner with regulatory colleagues on IND strategy, FDA interactions,...Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning + Contribute medical… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …team, which is responsible for 1) the creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the ... FDA and other regulatory agencies (eg, recall... Affairs, R&D, Operations, Service, Medical Affairs, Legal, Regional Compliance , and Post Market Quality on the review and… more
- Abbott (San Diego, CA)
- …Your work will support threat modeling, risk assessments, vulnerability management, and regulatory compliance , helping ensure our products are secure and ... cybersecurity into the product lifecycle** , ensuring our devices meet regulatory requirements and protect patient safety. **What You'll Work On** You'll… more