- 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
- Prime Matter Labs (Torrance, CA)
- …productivity. Develop and maintain supplier quality assurance programs aligned with FDA , ISO 22716 (GMP for cosmetics), and other applicable regulations. Conduct ... supplier audits, assessments, and risk evaluations to ensure compliance with quality standards. Collaborate with Supply Chain, R&D, Quality and Regulatory Affairs to qualify new suppliers and manage ongoing supplier performance. Lead investigations into… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of progressive… more
- Abbott (Alameda, CA)
- …processes and analytics. + Ensure compliance with QMS, EMS, GMP, FDA regulations, and company policies. **Required Qualifications** + Bachelor's Degree or ... equivalent combination of education and work experience **Preferred Qualifications** + MBA preferred + Professional certifications in Procurement or Supply Chain such as CPSM, CIPS, CPP, CPIM, or equivalent are highly desirable. + English proficiency required;… more
- ZOLL Medical Corporation (San Diego, CA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and the nature of associated clinical trials across phases. + Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical ... procedures. + Strong communication and organizational skills. + When needed, ability to travel. **People Leader Accountabilities** + Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the… more
- Sumitomo Pharma (Sacramento, CA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more