Interim Regulatory Affairs Manager
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Waals-Brabant Belgium.
The CompanyThey are an innovative company which is developing a revolutionairy new Medical Devices.
Role DescriptionDue to the temporary leave of the current RA Manager, the position of Regulatory Affairs is open. As mentioned the medical device is weeks away from market introduction, so the company is focussing on obtaining a CE-mark and in a later stadium also the 510(k) approval.
The role is focussing on pre-market Quality and Regulatory Medical Devices.
Responsibilities- Being the Lead regarding the compliance for EC, UL, FDA
- Experience with Notified Bodies is a pre
Requirements- Technical, Medical, Engineering Bachelor
- Experience in RA Medical Devices
- In depth knowledge in QMS and compliance systems
- Good experience in verification and validation of Medical Devices
- Good documentation experience
- Fluent in English
- Experience with Notified Bodies
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.