Minimum 2 years related experience in a medical device environment
Bachelor's Degree in a scientific discipline. MS in Regulatory is preferred.
Knowledge of US FDA regulations, ISO Standards, and GMPs
Some International regulatory experience and knowledge.
Coordinate documents from others for regulatory submissions of projects.
Support overall QMS system compliance: Maintain current knowledge base of existing and
emerging regulations, standards (i.e.21CFR 820, ISO 13485:2016) and other applicable
Standards, or guidance documents. Interpret and communicate regulatory rules or changes
through corporate policies and procedures.
Assist in document control and tracking (ECO, NMR, … and similar) and maintain system for
tracking changes in documents submitted to agencies or partners.
Review product labeling, and specification sheets, or test methods for compliance with applicable
regulations and policies.
Perform regulatory analyses of customer complaints
Proficiency in Words, Excel, Power Point
Impeccable attention to detail and organization skills
Demonstrate excellent people skills
Company Name: Vivalink, Inc.
Company address: 51 E. Campbell Ave Suite #160, Campbell, CA, 95008
A brief company introduction:
Silicon Valley based VivaLINK () is an innovative connected healthcare
devices company in its growth stage. The company develops wearable telemetry devices with
integrated biometric sensors designed to continuously monitor human vitals and other
indicators for medical and healthcare applications. These devices together with VivaLNK's
software development kit, related healthcare software products and services are offered to
enterprise customers under a Platform as a Service model. The VivaLNK platform has seen
rapid world-wide adoption in the last 12 months. Over 100 leading organizations, in 25
countries worldwide depend on our wearable human vitals sensors, software and services.
With great products, 15 patents and brilliant people, what we do, matters.
HR contact method: