Regulatory Affairs Specialist. Job in Campbell WestCoast-Jobs

  • Job Reference: 462851421-2
  • Date Posted: 2 January 2022
  • Recruiter: Vivalink,Inc
  • Location: Campbell, California
  • Salary: On Application
  • Sector: Government & Defence
  • Job Type: Permanent

Job Description

RA/QA Specialist

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

Company website:

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: