About the position
Healthy.io is the first company to successfully turn the smartphone camera into a clinical-grade medical device, enabling faster treatment and improved care for patients worldwide. Our products combine computer vision and machine learning technology with best-in-class UX design to create new clinical pathways through smartphone-powered urinalysis, digitized wound management, and beyond. Headquartered in Tel Aviv with 90 employees across the US and UK as the main markets the company operates in.
We are looking for a hands-on RA/QA Manager with regulatory and quality knowledge to join our RA/QA team for a 9 month maternity leave replacement position. As RA/QA Manager, you will work on product regulatory submissions, ensure that quality processes are being adhered to and adjust them when necessary along with company and/or work method changes, and interact and collaborate with product managers, production, and development teams, assisting with the overall maintenance of regulatory and quality documents.
Requirements
- Familiarity with standards and medical device/IVDs regulations
- 3-5 years experience in an RA/QA role
- Minimum 2 years experience in a medical device company
- 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.
Role & Responsibilities
- 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 and compliance with all applicable regulatory requirements of company products.
- Assisting in the planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices, including 510(k), technical files, AMAR submissions, Notification of Changes, Letters to File, etc.
- Preparation for tests, supporting engineering change (ECOs) in the product/quality system
- Learning new standards and training relevant staff
- Review manufacturing records and release company’s batches to the market according to the approved product specifications.
- 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.
or send your CV to [email protected]