Job Description. Job Description. Staff Customer Solutions Engineer. Location. Campbell, California (Hybrid / Remote Consideration). Company Website. www.vivalink.com. About Vivalink. Vivalink is a pioneering Silicon Valley-based healthcare technology company, enabling and supporting transformative healthcare initiatives such as Real-Time Virtual Wards, Hospital @ Home programs, Remote Patient Monitoring (RPM), and Mobile Cardiac Telemetry (MCT)....
Job Description. Job Description. Qualifications. 10 years related experience in a fast-paced medical device, including start-up environment. Bachelor’s Degree in a scientific discipline. Ability to review technical / regulatory documents and provide applicable inputs. Hands-on Experience of 510K and CE submissions for US FDA CE regulations, including SaMD. Hands on Experience with regulatory compliance for 21CFR 820, ISO 13485 : 2016, EU Medical...