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.

PlasFree ltd

נצרת

PlasFree ltd

נצרת
מלאה

Leads the preparation and submission of various documents to regulatory bodies worldwide, including the US FDA, EU Notified Body, Israeli MOH, etc.
Ensures all submissions comply with relevant regulations like ISO 13485, 21 CFR Part 820, and 93/42/EEC Directive.
Maintains and updates technical documentation for CE Marking and other regulatory requirements.
Oversees Device Labeling compliance for target markets.
Supports audits and inspections by regulatory authorities.
Document Control
Reviews and edits various documents related to quality systems, procedures, and regulatory submissions.
Manages the issuance Ensures proper document approval workflows and maintains document traceability.
Overall, this employee will plays a crucial role in:
Bringing medical devices to market by navigating the regulatory landscape.

Requirements:
Strong understanding of regulatory requirements for medical devices (ISO 13485, 21 CFR Part 820, 93/42/EEC Directive).
Experience drafting and submitting documents to regulatory agencies like FDA, EU Notified Body, and MOH Israel.
Excellent communication and writing skills in English (native level) and Hebrew.
Detail-oriented, with the ability to multitask and manage complex projects.
Team player with a scientific background and experience in medical devices).
Proficient in document management and).

This position is open to all candidates.