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.

חברה בתחום הייטק / חומרה / תוכנה / סייבר

פתח תקווה

חברה בתחום הייטק / חומרה / תוכנה / סייבר

פתח תקווה
מלאה

For a medical device start up company that developed an AI-driven software which offers Real-Time
.medical device for non-experts users
Submissions to FDA related to software and in communications with FDA, mostly 510(k). Build submissions, expert in writing, including software related sections. Has good communication skills and is up-to-date in Agencys requirements and guidelines

Requirements:
Bachelors degree or more in a scientific, engineering, or regulatory discipline (advanced degree preferred).
Extensive experience in Regulatory Affairs within the medical device industry, with a focus on FDA regulations.
In-depth knowledge of the FDA regulations (21 CFR), ISO standards, EU Medical Device Regulation (MDR 2017/745), and potentially other global medical device regulations.
Experience with technical file creation, clinical evaluations, risk managementot, and CE marking processes, as well as FDA submissions.
Strong understanding of global regulatory requirements for medical devices
Excellent communication and interpersonal skills, with the ability to interact effectively with internal teams, regulatory bodies, and external stakeholders.
Strong project management skills, with an ability to work independently and in teams.

This position is open to all candidates.