Regulatory Affairs Manager
Location: NetherlandsSIRE 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 couldn’t 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 Noord-Brabant Netherlands.
They are a market leader within the international biotechnology industry. They offer patients optimal service and strive to become 'The Best'. To become 'The Best', they are driven by technology, science and innovation.
ROLE DESCRIPTION
As the Regulatory Affairs Manager you will be responsible for both Global and Regulatory Affairs. You will be guiding and coaching a team which dedicated to the manufacturing site organisations. You as a manager will become part of the Site Regulatory group which consists of other specialists from various continents. As part of your responsibility you are to one who is constantly in contact with the Global RA Director. This project will be for 5 months with the possibility to extend. Overall, you will receive a great opportunity to extend your experience in such an innovative-, and technology-driven organisation which develops and grows every day.
RESPONSIBILITIES
Are you a specialist within Regulatory Affairs? This could be the position for you. In this position you will assist multiple teams regarding Regulatory Affairs. Next to that you will be the first to be reached at the spot regarding concerning RA issues. You will also interact among the different sites to investigate significant changes and requirements. Other responsibilities will include:
* Create and give training
* Interact with the team to increase and develop awareness of Regulatory Affairs
* Gain insights into licenses and apply these on the site
REQUIREMENTS
* Bsc in Life Sciences (preferred Medical Devices)
* 3-5 years of experience within the medical devices industry
* Experience with Good Manufacturing Practice
* Various experience with RA and CMC regulatory specifics
* Knowledge of industry related regulations and guidelines for Europe and Worldwide
* Fluent in English and Dutch
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.
