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QA & RA manager for a rapidly growing multinational
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Jobcode:
8375
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SIRE Life Sciences is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldnt stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment, making sure we, or better yet, you find the right career!



THE COMPANY


Our client is a professional Medical Devices organization, based in Netherlands.


This client is operating internationally, and is currently rapidly growing. They are represented in more than 50 countries across the globe. Their focus is on the development of highly innovative medical device products which are aimed to treat and serve patients with cardiovascular and peripheral diseases.



ROLE DESCRIPTION


You will enter a professional, yet informal business setting which gives plenty of room for the development of your own vision. In your role as QA/ RA manager, you will overview the clients QMS, interact on the changes within the market, and be on top of the discrepancies within regulations and legislation. You will be the lead of a team in which you are the overall responsible for the Quality Assurance and Regulatory Affairs. Furthermore, your role involves creating your own strategy and tools for the Quality and Regulatory department. As this organisation is rapidly developing you will get the opportunity to fill in a challenging and dynamic position situated at the core of the company. This project lasts for 6 months with a possibility for 1 month extra.


RESPONSIBILITIES


As mentioned previously you are the representative of the organisation when it comes down to Quality Assurance and Regulatory Affairs. Next to that, your responsibilities involve:

Having a supportive and advisory role as team lead, and for subsidiaries of the organisation

Creating awareness and spread of knowledge regarding QA and RA related topics and procedures in- and outside the organisation

Overviewing the ongoing changes and points of improvement for the Quality Management System

Investigating the discrepancies within regulation and carry out to collect up to date documentation

Establishment and maintenance of internal and external relationships


REQUIREMENTS


Bachelor in Science

Minimal 6 years of experience within the Medical Devices industry

Minimal 3 years of experience with Medical Devices RA and QA

Excellent knowledge of ISO13485

Experience in working with notified bodies and other authorities

Fluency in Dutch and English

Evidence of management and leadership skills

Eye for detail and strong analytical skills




Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.




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