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Regulatory Affairs Assistant/Manager

Job Title: Regulatory Affairs Assistant/Manager
Contract Type: Permanent
Location: Düsseldorf
Specialisation:
Ref: DE__000024[280]
Published: 26 days ago

Overview

As the regulatory environment for medical devices is going to change with the upcoming introdction of the New Medical Device Regulations (MDR), we are looking for a Regulatory Affairs specialist.


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