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 אחר

מספר מקומות

חברה בתחום אחר

מספר מקומות
מלאה

EU MDR Compliance: Contribute to preparation and implementation of MDR requirements for medical devices, ensuring full compliance with European regulations and industry standards.
Global Regulatory Compliance: Coordinate the regulatory strategy for markets beyond the EU, including the US (FDA) and other relevant international territories.
Regulatory Documentation: Prepare, review, and maintain regulatory documentation for multiple regions, including technical files, clinical evaluation reports (CERs), risk management files, and declarations of conformity in line with MDR and other global requirements.
Liaison with Notified Bodies and Regulatory Agencies: Serve as one of the point of contact with Notified Bodies (for MDR) and regulatory authorities (e.g., FDA, Health Canada, TGA,) for all matters related to device certification, audits, and inspections.

Requirements:
Bachelors degree in a scientific, engineering, or regulatory discipline.
Extensive experience in Regulatory Affairs within the medical device industry, with a focus on MDR and other global regulations.
In-depth knowledge of the EU Medical Device Regulation (MDR 2017/745), FDA regulations (21 CFR), ISO standards, and other global medical device regulations.
Experience with technical file creation, clinical evaluations, risk managementot, and CE marking processes, as well as FDA submissions.
Familiarity with Notified Bodies, regulatory agencies, and audit processes in the EU, US, and other international markets.
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.

This position is open to all candidates.