- Medtronic (Irvine, CA)
- …engineering reports to provide technical explanation to support domestic and international regulatory submissions. + Leverage engineering knowledge in conducting ... Ensure adherence to product specifications, industry standards, and quality and regulatory procedures and requirements. + Create innovative technical solutions which… more
- Edwards Lifesciences (Irvine, CA)
- …and understanding of FDA's 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards. + Experience and/or proficient knowledge of Design ... strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Familiarity with risk management activities that support BD's compliance with various international regulatory bodies, including ISO 14971 and ISO 13485. IEC ... actions taken, aligned with BD's quality systems and ensuring compliance with regulatory standards and practices. + Lead remediation efforts for updating risk… more
- Edwards Lifesciences (CA)
- …Mistake Proofing, Statistical Process Control,). + In-depth knowledge of domestic and international regulatory requirements (eg, FDA, GMPs, and ISO/EN standards) ... + Proven successful project management leadership skills + Project Management Certification or experience. + Knowledge of DMAIC Six Sigma concepts + In-depth knowledge of Quality Management Systems and Processes + Extensive knowledge and understanding and… more
- Edwards Lifesciences (Irvine, CA)
- …of quality engineering processes and/or systems + Expert knowledge of domestic and international regulatory requirements (eg, FDA, GMPs, and ISO/EN standards) + ... Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing + Demonstrated ability to direct teams and provide coaching and… more
- AbbVie (Irvine, CA)
- …(QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies. Additional Information ... All your information will be kept confidential according to EEO guidelines. Salary: $35,000 - $172,500 AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal… more
- AbbVie (Pleasanton, CA)
- …(QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies. Additional Information ... Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it… more
- Stratolaunch, LLC (Mojave, CA)
- …supports planned launches + Represent Stratolaunch to executive level national and international decision makers for regulatory or range authorizations + Provide ... **ESSENTIAL RESPONSIBILITIES:** + Lead the development and implementation of a consistent regulatory approach to be used as the baseline for launch operations +… more
- US Tech Solutions (San Bruno, CA)
- …of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified ... providing training and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical devices from concept to release,… more
- Deloitte (Costa Mesa, CA)
- Are you a process-oriented thinker with experience in international tax compliance? Do phrases like "best practices," "leading edge technology," and "maximum ... efficiency" pique your interest? Do you enjoy providing international compliance and process improvement advice to US and...meet the challenges of a rapidly evolving market and regulatory environment. Our team members are highly knowledgeable and… more