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Regulatory Affairs Assistant/Manager

Job Title: Regulatory Affairs Assistant/Manager
Contract Type: Permanent
Location: Düsseldorf
Specialisation:
Reference: DE__000024[280]
Published: 16 days ago

Overview

A Japanese medical technology company in Düsseldorf is looking for a Regulatory Affairs Assistant/Manager as the regulatory environment for medical devices is going to change with the upcoming introduction of the New Medical Device Regulations (MDR).

Responsibilities

Track and evaluate the regulatory environment of our business in Europe
Communicate with our RA-Department in Japan to ensure effective information exchange
Ensure the certification documents of our products are up-to-date
Support & Advise the management on regulatory issues
Revise Regulatory documents
Assistance with document/data maintenance and updating
Research activities

Requirements

-Academic Background in one or more of the following: Pharmacy, Medicine, Medicine Technology, Biology, Biochemistry
-Knowledge or Qualification in legal studies is preferable
-Work experience in the Regulatory Affairs is desirable but not mandatory
-German: Mother tongue or business fluent, English: Business fluent, Japanese language is a plus