עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
מלאה
we are 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.
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 companys 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.
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.
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 companys 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.
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.
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.
This position is open to all candidates.
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
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