- Imperative Care (Campbell, CA)
- …advanced expertise to work directly with customer representatives, marketing, physicians, pre- clinical engineering, and regulatory affairs to understand user ... in compliance with customer needs, company quality systems, budget, schedule and regulatory requirements of the countries into which the products will be marketed.… more
- Abbott (Pleasanton, CA)
- …Quality System element. * Works cross functionally with development/manufacturing/quality/ regulatory / clinical to establish product risk documentation. * ... or maintain product risk assessments. * Perform Health Hazard and Regulatory Risk Evaluations. **Required Qualifications** + Bachelor's degree in engineering or… more
- Stryker (San Jose, CA)
- …per applicable regulations. + Work cooperatively with R&D, Quality, Manufacturing, Regulatory , Clinical , Marketing and Project Management to ensure project ... and equipment based on analysis of specifications, reliability, and regulatory requirements. + Support capital acquisition activity including equipment selection,… 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** ... you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development, regulatory … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- … trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be ... + ** Regulatory Authority Engagement:** Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any… more
- Abbott (Alameda, CA)
- …obtain submission approval, working with in-country affiliates + Evaluate risk of and regulatory solutions to product and clinical safety issues during ... their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager** will work on-site in Alameda, CA for our Diabetes… more
- Oura (San Francisco, CA)
- …and international registrations. + Partner with science, data science, engineering, clinical , marketing, and legal teams to integrate regulatory requirements ... heart health tracking. We view Oura Ring as a clinical grade device in a consumer package rather than...of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key… more
- Sharp HealthCare (San Diego, CA)
- …meets all third-payer (Medicare, PPO, Work Comp and HMO) and regulatory requirements. Clinical documentation, including evaluations, progress notes, discharge ... & Hearing Aid Dispensers Board; Master's Degree; Certificate of Clinical Competence in Speech-Language Pathology (CCC-SLP) - The American Speech-Language-Hearing… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- … clinical studies in digital health * Oversee and coordinate clinical research operations, including regulatory compliance and participant engagement * ... ideal candidate will have demonstrated expertise in the following areas: * Clinical research coordination and operational management * Human motion analysis, gait… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and ... international regulatory environments....(THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported… more