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RA/QA Specialist

RA/QA | Tel Aviv-Yafo, IL

About the position

Healthy.io turns the smartphone camera into a clinical-grade medical device, improving access to healthcare across the globe. We create products and services at the intersection of clinical and consumer technology. We empower patients to take care into their own hands while working closely with leading healthcare organizations to deliver better outcomes. 

As we rapidly grow, we are looking for an RA/QA Specialist with regulatory and quality knowledge to join our RA/QA team. As RA/QA Specialist you will write submissions, fill out all forms, work and interact with product managers, production, and development teams, as well as assist with the overall maintenance of regulatory documents. The RA/QA Specialist will be responsible for assisting in planning, coordinating, and conducting product submission and evaluations of product changes. The role will also involve ensuring compliance with regulations, standards, and protocols, adherence to product objectives and product plans, and supporting the smooth operation and compliance to RA/QA requirements. In addition, the RA/QA Specialist will take part and lead Quality Management System (QMS) activities to comply with EN ISO 13485:2016 standard, FDA QSR regulations, and other applicable standards for the assurance of the quality of company products and support RA projects, including the transition of the company to the new European regulation system: MDR and IVDR.

Requirements
  • Familiarity with standards and medical device regulations
  • Minimum 2 years experience in RA/QA for medical device companies
  • Previous experience with FDA QSR regulations; past experience commercializing products in the US and FDA inspections is a plus.
  • Experience in quality systems complying with EN ISO 13485:2016 standard and the MDR, IVDR European regulations. 
  • Experience with software companies - advantage 
  • Experience with design controls and PMS - advantage
  • Experience with clinical trials - advantage
  • Academic degree in exact sciences such as chemistry or biology - advantage 
  • Attention to detail and ability to manage multiple tasks
  • Ambitious, constantly thinking of how to tackle issues and improve processes
  • High verbal and written skills in English.

or send your CV to [email protected]