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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: 29 days ago

Overview

As the regulatory environment for medical devices is going to change with the upcoming introduction of the New Medical Device Regulations (MDR), we are looking for a Regulatory Affairs specialist for our client, Japanese medical devices company in Düsseldorf.


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 isses
-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