- Stryker (San Jose, CA)
- …+ Collaborate with cross-functional teams to ensure compliance with ISO 13485, FDA regulations, and internal quality systems. + Promote a customer-centric quality ... Management, and Supplier Quality. + Familiarity with ISO 13485, ISO 14971, and FDA regulations. + Excellent communication and leadership skills; ability to train and… more
- Imperative Care (Campbell, CA)
- …methods (DOE, SPC) with proficiency in Excel and Minitab. + Solid knowledge of FDA Design Control, DFSS/DFM tools, GMP/GDP, and relevant standards (ISO 13485, FDA ... QSR). + Excellent critical thinking - able to connect cause and effect, prioritize under constraints, and deliver practical solutions. + Experience in pilot and production line setup, validation, and scale-up. + Proven ability to work independently and to… more
- Bristol Myers Squibb (San Diego, CA)
- …Advise on global regulatory matters relevant to radiopharmaceuticals, including FDA regulations governing drug development, clinical trials, approval, labeling, ... in the biotech, pharmaceutical or life sciences industry, including significant FDA regulatory and healthcare law counseling. + Prior experience supporting oncology,… more
- Terumo Neuro (Aliso Viejo, CA)
- …+ Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room monitoring and validation activities, ... four (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring. 4. EN… more
- Datavant (Sacramento, CA)
- …and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program ... software organizations. + Strong working knowledge of relevant regulations and frameworks, including ** FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** ,… more
- Genentech (South San Francisco, CA)
- …and legal direction on, healthcare fraud and abuse laws, pricing, FDA labeling and promotional matters, cGMP compliance, products liability, antitrust, privacy ... and partnerships; + Advising regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; + Counseling… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. + ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more
- Abbott (Alameda, CA)
- …+ Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate ... software validation experience in a medical device company + Knowledge of FDA QSR, ISO13485, ISO14971 and IEC62304 **Preferred Qualifications** + Knowledge of Jira,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + Monitor training compliance ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs… more
- Stanford Health Care (Palo Alto, CA)
- …Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label ... use) require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room (OR). + Acts as first or second assistant under the supervision of an approved supervising… more