- Abbott (Alameda, CA)
- … product return workflows, and ensure compliance with global regulatory standards. By aligning business needs with technical capabilities, this position ... This is not a remote role/opportunity.** **IT Business Relationship Manager - Complaint Process Automation** plays a critical role...the organization. + Ensure all automation processes comply with FDA , ISO 13485, and other relevant regulatory … more
- Stryker (Irvine, CA)
- Stryker - Inari Medical is seeking a strategic **Senior Manager , Quality Management Systems** in **Irvine, CA!** In this onsite role, you will lead the governance ... advancement of our Quality Change Management subsystem, ensuring every product , process, and documentation change strengthens compliance, efficiency, and innovation.… more
- Cordis (Irvine, CA)
- …address unmet and critical medical needs. **Responsibilities** The R&D Program Manager leads cross-functional project teams to ensure efficient planning, execution, ... and delivery of product development initiatives within the SELUTION (TM) platform. The...role emphasizes program leadership, risk management, and adherence to regulatory and quality frameworks **Key Responsibilities** + Lead and… more
- Stryker (Irvine, CA)
- …guiding teams through risk management (eg, FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO ... team where innovation meets impact!** Stryker - Inari Medical is hiring a ** Manager , Quality Engineering** in **Irvine, California** ! In this role, you'll lead and… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... **Position Overview** The Account Manager - Oil & Gas position will be...our technical staff for exposure information, problem solving and product testing at current and potential customers. + Communicate… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Senior Manager , Medical Affairs MMS Infusion is primarily responsible as the "voice of the end user" to help ensure the BD infusion ... Medical Affairs (MA) plays a significant role in new product development to include Key Opinion Leader engagement on...all final reviews. You will assist cross-functional teams with FDA 510(k) submissions, audits, and other tasks related to… more
- Chipotle Mexican Grill (Newport Beach, CA)
- …and professional groups such as CPS, LGMA, etc. + Accustomed to working with FDA , USDA, State and Local Regulatory Agencies. + Bilingual in English/Spanish ... to everyone. **THE OPPORTUNITY** As the Produce Senior FSQA Manager , you will help to ensure that all fresh...supplier scorecards, CMG FSQA Produce Manual, and digitization of product specifications. + Assist or lead traceability efforts with… more
- GRAIL (Menlo Park, CA)
- …companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities for one or multiple diagnostic ... product development studies in support of GRAIL's robust clinical...on-site. Your specific schedule, determined in collaboration with your manager , will align with team and business needs and… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …leadership position oversees four key areas: Facilities, Planned Maintenance, Product Development Engineering, and Process/Controls. The role drives comprehensive ... Design of Experiments). + Knowledgeable on materials for Sealant Franchise product designs in areas of responsibility. + Drives qualification and validation… more
- Lilly (San Diego, CA)
- …expertise to regulatory scientists. + Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug ... clinical trials in support of registration and commercialization of the product ; the implementation of global clinical trials; the reporting of adverse… more