- Sumitomo Pharma (Sacramento, CA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- Would you like to join an international team working to improve the future of healthcare ? Do you want to enhance the lives of millions of people? Grifols is a global ... healthcare company that since 1909 has been working to...Maintain a quality presence to ensure compliance with all regulatory requirements. + Maintain current knowledge of regulatory… more
- Stryker (San Jose, CA)
- …and update internal SOPs and work instructions in response to evolving regulatory standards. + Support regulatory submissions (eg, 510(k)) and collaborate ... teams and authorities. + Participate in internal and external audits ( FDA , notified bodies), addressing sterilization and biocompatibility topics. + Apply ISO,… more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …- $112,200 yearly (commensurate with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations within the ... personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure Quality incidents… more
- Abbott (Sylmar, CA)
- …+ Lead data generation, validation protocols, and submission strategies for new FDA 510(k) AI-based SaMD modules. Support international regulatory submissions. + ... Abbott is a global healthcare leader that helps people live more fully...Ensure AI solutions comply with relevant regulatory standards and collaborate with Regulatory Affairs… more
- Biomat USA, Inc. (Upland, CA)
- Would you like to join an international team working to improve the future of healthcare ? Do you want to enhance the lives of millions of people? Grifols is a global ... healthcare company that since 1909 has been working to...for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance, and achievement of production goals. This role… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …on-time quality assessments, medical device reporting and health risk assessments to the FDA and other regulatory bodies + Provide subject matter expertise into ... trials for medical device development and submission to the FDA and other regulatory bodies + Identify...+ Minimum 5-10 years of experience in a diagnostic healthcare environment + Prior experience in US LDT development… more
- Fujifilm (Sacramento, CA)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... America Corporation, we're redefining innovation across the industries we touch-from healthcare and photography to semiconductors and data storage. With roots in… more
- Abbott (Alameda, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Abbott is a global healthcare leader that helps people live more fully...the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable… more
- IQVIA (San Francisco, CA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability… more