- Abbott (Alameda, CA)
- …advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input. + Assist with promotional content ... development and review for compliance before distribution. + Assist in Regulatory ...approval requirements as needed. **Core Responsibilities** + Prepares robust regulatory applications (either for FDA or for… more
- Cordis (Santa Clara, CA)
- …and collaborate with suppliers to improve product quality. + Support regulatory compliance by ensuring adherence to FDA and other relevant standards. + ... + Perform inspections and audits of manufacturing processes to ensure compliance with quality standards and regulations. + Collaborate with cross-functional teams… more
- Sumitomo Pharma (Sacramento, CA)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
- Barry Callebaut (American Canyon, CA)
- …continuous improvement, accountability, and teamwork. Regulatory Compliance * Ensure compliance with OSHA, FDA , USDA, EPA, and other regulatory ... Sheets (SDS). * Coordinate with the safety team for audits and regulatory compliance . Good Work Practices (GPT) * Ensure sanitation and cleaning practices align… 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...promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal… more
- Merck (San Diego, CA)
- …and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and ... Skills:** Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical … 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...related field (advanced degree preferred). + 5+ years of regulatory or compliance experience in medical devices,… more
- Kelly Services (Valencia, CA)
- …in a similar role. + Proven experience with 5 years or more of FDA submissions and international regulatory compliance . + Lead Auditor certification ... for a leading client. In this role, you'll ensure compliance with FDA , ISO, and international regulations... programs across two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). +… more
- GRAIL (Menlo Park, CA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on… more
- Kelly Services (Oakland, CA)
- …responsible for supporting the development and operations team's compliance with FDA , CLIA, CAP, IVDR, and other global regulatory requirements. This ... in multiple ex-US jurisdictions, including the EU, APAC, Australia, and assume regulatory responsibility for compliance with IVDR. . Develops and executes… more