- Kelly Services (Sacramento, CA)
- …Science & Clinical is seeking an **Environmental Health & Safety (EHS) Manager ** for a **direct-hire** position at a cutting-edge Biotechnology **Client** in ... across all facilities. This role ensures compliance with OSHA, EPA, DEA, FDA , and state regulatory standards, promotes a safe and environmentally conscious… more
- Edwards Lifesciences (Irvine, CA)
- …policies, procedures and guidelines relevant to local and/or global supply chain including FDA and ISO laws and regulations * Ability to transfer essential knowledge ... and mentor other team members on specialized skills * Strict attention to detail * Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization * Ability to manage… more
- Edwards Lifesciences (Sacramento, CA)
- …lives. Join us and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing projects and team operations in compliance with ... and performance oversight. + Expertise in medical writing processes, regulatory requirements ( FDA , EU MDR), GCP, and ICH guidelines. + Advanced knowledge of… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Clinical Operations team based in Santa Monica as a Senior Clinical Trial Manager , specializing in Late Phase studies. **Essential Duties and Job Functions:** + ... is desired but not essential * Thorough knowledge and understanding of FDA Regulations, GvP and clinical trial conduct standards * experience, interpreting, and… more
- Stryker (Irvine, CA)
- Stryker - Inari Medical is seeking a strategic **Senior Manager , Quality Management Systems** in **Irvine, CA!** In this onsite role, you will lead the governance ... in quality assurance. + Strong knowledge of QMS regulations and standards (eg, FDA CFR, ISO 13485, MDSAP, EU MDR). + Experience with electronic QMS platforms… more
- Danaher Corporation (West Sacramento, CA)
- …which makes everything possible. The Global Commercial Marketing Manager - Microbiology is responsible for driving brand activation ... working in a Healthcare regulated Product Development and Sales environment, eg, FDA , IVD Beckman Coulter Diagnostics, a Danaher operating company, offers a broad… more
- Ascendis Pharma (Palo Alto, CA)
- …workplace for employees to grow and develop their skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project ... knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA , EMA, ICH, etc.) and global eCTD submission requirements (eg, US,… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …**It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager , Clinical Research Regulatory Affairs is tasked with oversight and ... regulatory experience. + Advanced knowledge of Food and Drug Administration ( FDA ) regulations and International Conference of Harmonisation (ICH) and Good Clinical… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Senior Manager , Medical Affairs MMS Infusion is primarily responsible as the "voice of the end user" to help ensure the BD infusion ... take part in all final reviews. You will assist cross-functional teams with FDA 510(k) submissions, audits, and other tasks related to Regulatory compliance and… more
- Abbott (Alameda, CA)
- …mothers, female executives, and scientists. **The Opportunity** The **Systems Engineering Manager , Sustaining** will work within R&D from either our Alameda, CA ... development including telemetry. + Experience with medical device systems development per FDA and EU design control regulations. + Experience with model based… more