- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …top-notch digital experiences for US customers. We are seeking a Senior Manager of Digital Marketing Operations reporting directly to the Director of Digital ... highly regulated industries (pharmaceuticals or healthcare) with thorough knowledge of FDA guidelines and US data privacy regulations. + Excellent communication… more
- Cordis (Irvine, CA)
- …address unmet and critical medical needs. **Responsibilities** The R&D Program Manager leads cross-functional project teams to ensure efficient planning, execution, ... Bachelor's degree in Engineering or related field. + Mastery of FDA design controls and documentation requirements. **Preferred Qualifications** + PMP certification… more
- Stryker (Irvine, CA)
- …team where innovation meets impact!** Stryker - Inari Medical is hiring a ** Manager , Quality Engineering** in **Irvine, California** ! In this role, you'll lead and ... FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485. + **Make independent decisions** on… more
- Pfizer (South San Francisco, CA)
- …knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Extensive understanding of related disciplines, ... eg, Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance. + Experience working on large data sets. + Proficiency with Microsoft Office and relevant scientific software + Effective… more
- BeOne Medicines (San Mateo, CA)
- …research organization experience + Basic knowledge of global regulations and guidelines ( FDA , ICH) on the drug development process + Basic knowledge of electronic ... Common Technical Document (eCTD) requirements + Demonstrated capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write concise unambiguous medical text in English + Working knowledge of an electronic document… more