- Imperative Care (Campbell, CA)
- …ensure compliance with domestic and international regulatory standards (eg, FDA , CE marking, etc.). + Build and sustain relationships with cross-functional peers ... + Participate in audits by external bodies (Notified Body, FDA , etc.) and internal audits to maintain regulatory ...FDA , etc.) and internal audits to maintain regulatory compliance . + Oversee quality and compliance issues,… more
- Neotech (Chatsworth, CA)
- …inspection and testing. + Support of calibration and equipment databases to ensure compliance with customer requirements, FDA regulations & ISO specifications. + ... Support Corrective Action/Preventative Action initiatives relating to assignment and verification & follow up from a 7-step problem solving methodology. + Support Lean and Shingo initiatives by team participation and action item support, with required metric… more
- Astrix Technology (Los Angeles, CA)
- …**Contract Opportunity** **Responsibilities:** + Review, test, and sample products to ensure compliance with specifications, SOPs, FDA , and cGMP regulations. + ... Conduct inspections and generate QA reports. + Identify and report non-conformities, manage containment, and assist in line failure investigations. + Maintain up-to-date QA documentation and close out OTC orders. + Develop masters, manage retain samples, and… more
- Abbott (Alameda, CA)
- …materials while working with Marketing teams to provide regulatory strategy and compliance input. + Assist with promotional content development and review for ... compliance before distribution. + Assist in Regulatory Affairs Ad...**Core Responsibilities** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental… more
- Abbott (Alameda, CA)
- …role for the Staff Quality Auditor will serve as experts for the compliance team with respect to observation tracking, auditing, regulations and standards and the ... This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as...the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable… more
- Abbott (Sylmar, CA)
- …software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the application of ... Follow approved Design Control procedures for software development in accordance with FDA guidelines. + Contributes to and supports root-cause analysis of failures.… more
- VTI Life Sciences (San Diego, CA)
- …are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), ... attendance and project coordination. + Provide all services in accordance with FDA cGxP guidelines and regulations. QUALIFICATIONS: + Bachelor's degree or higher in… more
- Abbott (San Diego, CA)
- …will support threat modeling, risk assessments, vulnerability management, and regulatory compliance , helping ensure our products are secure and resilient. + ... risk assessments and contribute to risk mitigation strategies aligned with FDA and international cybersecurity guidance. + Implementation of security risk controls… 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 letters) are...Regulatory Affairs, R&D, Operations, Service, Medical Affairs, Legal, Regional Compliance , and Post Market Quality on the review and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …planning and execution of Sustaining Engineering activities to keep products in compliance with applicable standards and improve customer experience. This role also ... operating with independence but under oversight from senior quality and regulatory compliance leaders. **Key Responsibilities** + This leader will provide input into… more
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