- Gilead Sciences, Inc. (Foster City, CA)
- …for clinical studies, and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, ... EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses. + Expert in leading through ambiguity, can assess options quickly and… more
- Stanford Health Care (Palo Alto, CA)
- …clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, sample ... Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs,… more
- US Tech Solutions (San Bruno, CA)
- …Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory ... and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical devices from...Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products… more
- Kelly Services (Sacramento, CA)
- …includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (eg, FDA , EMA, MHRA). The QA Manager will ... and audit readiness. The role requires close collaboration with production, QC, regulatory affairs, and engineering teams to ensure consistent product quality and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with process scale-up to pilot and manufacturing scale equipment. + Understanding of FDA , EMA, and ICH regulatory guidelines related to cGMP. + Excellent ... communication, technical writing, and presentation skills and aptitude for creative problem solving. + Demonstrated ability to collaborate and influence cross-functionally. + Experience in statistics, design-of-experiments, and data analysis (eg JMP,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …tools + Certification as a trainer or facilitator + Experience in a regulatory environment ( FDA /ICH) or field within Healthcare, Life Science or Diagnostics. ... + MBA preferred. **_Location_** + This is an office-based hybrid role in any of the following locations: + San Diego, CA (preferred) + Durham, NC + Franklin Lakes, NJ + Monday, Tuesday, Wednesday, and Thursday are required in-office days each week. + Travel up… more
- Astrix Technology (Pomona, CA)
- …in food manufacturing environment. + Strong understanding of food safety programs and regulatory requirements ( FDA , USDA, AIB, HACCP, GMP, Allergen Programs). + ... Excellent verbal and written communication skills in English. + Leadership skills with ability to motivate and guide team members. _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who… more
- Abbott (Sylmar, CA)
- …working mothers, female executives, and scientists. The Opportunity We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Sylmar, CA or ... AZ. As an individual contributor, the function of a Regulatory Affairs Specialist I is to provide support for...assessments. What You'll Work On + Annual Reports - FDA APRs, ARCs (support), Custom Devices, Ics (support). Tracking… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …making a positive impact in the cancer field. The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial ... regulatory strategy and direction to enable the US business...as appropriate. + Serve as a liaison to the FDA 's Advertising and Promotional Labeling Branch for respective product(s)… more
- Kelly Services (Petaluma, CA)
- …communication of findings. + Participate in internal/external audits and ensure regulatory adherence (GMP, FDA ). **Qualifications:** + Bachelor's or Master's ... setting, transitioning the company's QC testing in-house, and ensuring regulatory compliance. This position requires extensive experience in microbiological testing,… more