- Amgen (Thousand Oaks, CA)
- …the lives of patients while transforming your career. **CD&A - Competitive Intelligence Manager , R&D CI** **What you will do** Let's do this. Let's change the ... BioMedTracker, Cortellis Intelligence, Evaluate Pharma, Datamonitor, IPD analytics, PharmaProjects, Drugs@ FDA , PubMed, AlphaSense, Factset, and USPTO patents + Work… more
- Edwards Lifesciences (San Francisco, CA)
- …the Cordella PA Sensor is revolutionizing how heart failure is managed, improving quality of life while slashing hospital admissions and health care costs along the ... You! IHFM has achieved a significant milestone and received FDA approval for our Cordella PA Sensor. Join us...revolutionary heart failure management system! As the Area Sales Manager at IHFM, you will play a pioneering role… more
- Gilead Sciences, Inc. (Foster City, CA)
- …SOPs, company policies and regulatory guidelines to provide timely and high- quality clinical data that supports global registration and commercialization of Gilead's ... interprets these. + Thorough knowledge of Food & Drug Administration ( FDA ), European Medicines Agency (EMA), and other applicable national regulations, International… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes **Additional ... organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of… more
- ZOLL Medical Corporation (San Francisco, CA)
- …sleep disorders. Our core product is the WatchPAT(R)️ family, a revolutionary FDA -cleared portable home sleep apnea test device, that is based on proprietary ... patients and provide testing to promote wellness and enhance overall quality of life. WatchPAT(R)️ is commercially available within major markets including… more
- Kelly Services (Anaheim, CA)
- **Director of Quality and Regulatory Affairs** Kelly(R) Science & Clinical is seeking a **Director of Quality and Regulatory Affairs** for a **direct-hire** ... role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development, regulatory… more
- Medtronic (Los Angeles, CA)
- …which look and feel more like consumer devices. We are looking for an Associate Quality Systems Specialist who can help us continue to make devices more robust and ... Experience with Oracle Agile, Trackwise and/or PowerBI systems + Experience in FDA , Certifying Body and/or Notified Body audits/inspections + Experience or training… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Quality Systems Senior Specialist is responsible for providing quality ... will ensure that all product, process or system related quality activities from raw material inspection through shipment of...required to prepare and present data during regulatory audits ( FDA , EMA, Anvisa, etc) and internal audits. *Interact with… more
- Cordis (Irvine, CA)
- … operations team for MDR, with potential for this position to assume the quality program manager on MDR. + Supplier Collaboration: Work closely with supplier ... solutions that address unmet and critical medical needs. The **Principal Manufacturing Quality Engineer** will be responsible for ensuring that our medical devices… more
- Abbott (Santa Clara, CA)
- …support manufacturing in the Structural Heart Division of Abbott, reporting to the Manager of Quality . + Conduct functional testing as required by component ... of employees, customers, contractors, and vendors. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulator + requirements.… more