- Oura (San Francisco, CA)
- …privacy and regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance : + Serve as the primary legal advisor ... on FDA , EU MDR, and other global health compliance requirements, and corporate regulatory risk for wearable-based health technology. + Provide strategic counsel… more
- Stanford Health Care (Palo Alto, CA)
- …is a Stanford Health Care job.** **A Brief Overview** Ensures organizational compliance with federal/state regulations and accreditation requirements ( FDA , CDPH, ... managers, nurse managers, etc.) on medication-related issues such as regulatory changes/ compliance , FDA drug recalls, drug information, sample medications,… more
- Kelly Services (Petaluma, CA)
- …oversight. **What You'll Do** + Partner with engineering and quality teams to ensure FDA compliance on validations, CAPAs, and process changes. + Prepare and ... support FDA submissions, including Class I device registrations, Class II...SOPs tied to engineering processes, quality systems, and labeling compliance . + Lead post-market surveillance activities such as complaint… more
- Robert Half Finance & Accounting (Oakland, CA)
- …optimization opportunities, and driving savings while maintaining the product quality required for FDA regulatory compliance . This is a hands-on role in an ... new product lines. Compliance and Reporting: + Ensure compliance with FDA regulations by working cross-functionally to effectively document and understand… more
- J&J Family of Companies (Santa Clara, CA)
- …cybersecurity, and product security requirements. + Support the regulatory submission process in compliance with FDA , EU MDR and other select country regulations ... of Companies, is recruiting for Head of Quality and Compliance (Q&C) Leader for our Monarch platform. This role...business functions, manage audit/inspection outcomes with Notified Bodies and FDA , lead and drive effective oversight of CAPA Program… more
- Actalent (Newbury Park, CA)
- …(HPLC) + Laboratory Operations + Gas Chromatography (GC) + Spectroscopy + cGMP Compliance + ICH Guidelines + FDA Regulatory Compliance Preferred ... ensure the integrity and quality of analytical data in compliance with regulatory standards. The ideal candidate will possess...Attributes + Familiarity with cGMP, ICH, and FDA regulatory guidelines. + Experience working with CMOs or… more
- ThermoFisher Scientific (San Francisco, CA)
- …Reports required. **Knowledge,** **Skills** **and Abilities:** + Exceptional cGMP, GLP and FDA compliance knowledge. + Possess a highly developed quality, ... Regulatory and Corporate Standards. Guide team to foster quality culture, compliance , and improvement. Lead team responsible for Document Control, Training,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …62304, ISO 14971). + Assess Cloud based multifunction SaMD products to determine compliance with FDA 's guidance on device versus non-device functionality. + ... determine whether submissions or notifications are required. + Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other… more
- ThermoFisher Scientific (San Francisco, CA)
- …dynamic environment. **Knowledge, Skills and Abilities** Outstanding cGMP, and FDA compliance knowledge. Proven leadership and problem-solving abilities. ... all aspects of daily operations, staffing, training, and troubleshooting, ensuring compliance with SOPs, safety guidelines, and regulatory expectations. + Provide… more
- Astrix Technology (San Bernardino, CA)
- …Control in the food industry. + In-depth knowledge of food safety programs and compliance ( FDA , USDA, HACCP, GMP, Allergen Programs). + Understanding of labeling ... This role plays a key part in upholding regulatory compliance and continuous improvement within our quality assurance operations....regulations including FDA , COOL, Prop 65, nutritional warnings, and health claims.… more