RA/QA Specialist

About the position

Healthy.io is one of the first companies to successfully turn a smartphone into a clinical-grade medical device enabling faster treatment and improved care for patients worldwide. Our products are powered by computer vision and machine learning and create new clinical pathways through smartphone-powered urinalysis and digitized wound management.

We are looking for a dynamic RA/QA Specialist with a strong foundation in regulatory and quality knowledge to join our RA/QA team.

The role of RA/QA Specialist is broad in that you will contribute to the writing and compiling of submissions, interact with product managers, production and development teams to ensure work is being carried out according to quality procedures, as well as assist with the overall maintenance of regulatory documents. More specifically, the RA/QA Specialist will be responsible for assisting in project 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 ISO 13485:2016 standard, FDA QSR regulations, and other applicable standards for the assurance of the quality of company products. In this regard, the focus will be on modifying and improving processes to best support scale, as well as auditing and control of suppliers.

Requirements
Familiarity with standards and medical device regulations.
2-3 years of experience in RA/QA for medical device companies.
Previous experience with FDA QSR regulations.
Experience in quality systems complying with ISO 13485:2016 standard and the MDR, IVDR European regulations.
Experience with design controls and PMS.
Experience auditing sites and suppliers.
Experience with software companies and IEC 62304 - advantage.
Academic degree in exact sciences such as chemistry or biology - preferred.
Attention to detail and ability to manage multiple tasks.
Ambitious, constantly thinking of how to tackle issues and improve processes, and quick to take an active role in driving work forward.
Ability to work independently with minimal direction and in a cross-functional team environment.
Collaborative team player.
Strong time management abilities to ensure timely task completion.
High verbal and written skills in English.
Role & Responsibilities
Supporting the activities and processes required to assure that products manufactured and distributed are in compliance with all applicable regulatory requirements including reviewing production records and releasing batches to the different markets.
Assisting in the planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices, including 510(K), AMAR submissions, Notification of changes, etc.
Supporting engineering changes in the product/quality system, including relevant validations.
Researching recently published guidances and learning new standards and subsequently training relevant staff.
Supporting Design Control and Software Development Life-Cycle (SDLC) processes and the creation and maintenance of products' Design History Files (DHFs).
Creation and maintenance of Device Master Records (DMRs) and Device History Records (DHRs).
Handling complaints and PMS activities, including vigilance and adverse events/recalls assessments.
Supplier assessments and audits.