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.

Regulatory Affairs Lead

QHR

מספר מקומות

Regulatory Affairs Lead

QHR

מספר מקומות
מלאה

Define and monitor external standards and guidelines for the companys activities
Coordinate, prepare, and review regulatory submissions for domestic and international projects. Prepare and support international submissions and international product releases (CE, FDA, etc.) in accordance with applicable SOPs. Prepare and maintain technical files and other regulatory ation, as necessary, to obtain and sustain product approval.
Interpret regulatory rules and rule changes to ensure that they are communicated through policies and procedures.;
Accompany R D projects. Provide regulatory input, review and approve projects inputs and outputs. Participate in product development, as required, to ensure the product follows regulatory requirements.
Work and communicate closely with company members to assist in obtaining regulatory approvals

Requirements:
A bachelors degree in a relevant field.
At least 5 years experience in regulatory affairs, at a Medical Device Company.
Familiarity with global regulations and standards.
Effective communication skills both verbally and in writing.
Good analytical skills.
High ability to work independently.
Self-motivated and proactive.
Fluent in English with excellent writing skills.
Excellent computer skills, including a working knowledge of Microsoft Office applications

This position is open to all candidates.