- Genentech (South San Francisco, CA)
- …I-IV), medical writing, and data analysis, with a thorough understanding of US regulatory / FDA requirements. + Demonstrated ability to coach, mentor, and develop ... leaders, and to build relationships with and identify the needs of patients, providers, and payers. + Substantive understanding of corporate legal and compliance, including GCP, OIG, and other guiding elements of the business. + Proven track record of… more
- Genentech (South San Francisco, CA)
- …I-IV), medical writing, and data analysis, with a thorough understanding of US regulatory / FDA requirements. + Demonstrated ability to coach, mentor, and develop ... leaders, and to build relationships with and identify the needs of patients, providers, and payers. + Substantive understanding of corporate legal and compliance, including GCP, OIG, and other guiding elements of the business. + Proven track record of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …testingprograms, policies,and procedures to ensure compliance withGxPstandards, corporate policies, FDA , EMA,and other regulatory body regulations and ... PDM functions including Product and Portfolio Strategy, Global Manufacturing,Supply Chain, Regulatory CMC, and the wider Quality organization to achieve business… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ Proven ability to work in matrixed environments + Strong knowledge of global regulatory requirements ( FDA , EMA, ICH, etc.). + Proficiency in safety databases ... safety profile of our innovative cell therapies, ensuring patient safety, regulatory compliance, and scientific excellence across the product lifecycle. **Key… more
- Edwards Lifesciences (Sacramento, CA)
- …including coaching and performance oversight. + Expertise in medical writing processes, regulatory requirements ( FDA , EU MDR), GCP, and ICH guidelines. + ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Astrix Technology (Chino, CA)
- …control leadership role. + Strong working knowledge of food safety programs and regulatory requirements ( FDA , USDA, HACCP, GMP, etc.). + Familiarity with food ... compliance with all applicable food safety and quality regulations (eg, GMP, HACCP, FDA , USDA). + Promote a culture of safety, quality, and continuous improvement. +… more
- Stryker (San Jose, CA)
- …Google, Microsoft, or similar, demonstrating strong technical skills + Experience with regulatory agencies ( FDA , MoH, TUV) and medical device regulations (820, ... root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria. + Translated design inputs into engineering specifications,… more
- Actalent (Irvine, CA)
- …Proofing). + Ability to read and interpret CAD drawings. + Experience interacting with regulatory agencies ( FDA , MoH, TUV). + Thorough knowledge of US and ... in design reviews to guarantee product excellence and adherence to global regulatory standards. What You'll Do + Develop quality assurance documentation for new… more
- Kerry (Commerce, CA)
- …compliant and safe foods.* Be the point person at the site for regulatory inspections ( FDA /CFIA), identify preserved (ie, organic, Kosher, HALAL), and customer ... problem solving.* Act as the primary technical liaison with customers, vendors, and regulatory agencies. Compensation Data The pay range for this position is $91,404… more
- Hologic (San Diego, CA)
- …technical expertise in molecular biology, testing laboratory practices (CLIA, CAP), and regulatory environments ( FDA , ISO, CE Mark). + Proven success leading ... You'll Do:** + **Strategic Leadership:** Partner with marketing, operations, quality, regulatory , and commercial teams to define and execute product lifecycle… more