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מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.

חברה בתחום פארמה וביוטק

קיסריה

חברה בתחום פארמה וביוטק

קיסריה
מלאה
14,000-19,000 ₪ הערכה מבוססת AI ולא שכר שהתקבל מהמעסיק
הערכה מבוססת AI ולא שכר של המעסיק

The Regulatory Affairs Specialist will be part of the Regulatory team at the Caesarea site, reporting to Regulatory Affairs Manager, supporting ongoing activities as required. The individual will serve as Regulatory Affairs representative in various workstreams.
Responsibilities may include the following and other duties may be assigned:

Regulatory assessments and registrations worldwide
Write, update and maintain technical files for Class I, IIa and IIb
Support global regulatory requirements and submissions
Support QMS changes, PMS and CAPA activities related to the regulatory field
Responsible for labeling requirements and compliance
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

R44331

Requirements:
A Bachler's degree in related scientific or engineering discipline
Minimum of 3 years of related experience
Strong understanding of medical device regulations and standards, especially US (FDA) and EU (MDD/MDR)
Experience with submissions in different territories
Experience in interpreting and applying regulatory guidelines and standards
Excellent attention to detail and organizational skills
Ability to manage multiple projects and deadlines
Effective communication skills to liaise with regulatory agencies and internal teams
Fluent in Hebrew and English (verbal and written communication skills

This position is open to all candidates.