Interim Quality Assurance & Regulatory Affairs Manager
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 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 organization, based in Gelderland Netherlands.
is an innovative company which is developing a revolutionairy new surgical medical device. The development is almost finalized and the market introduction is only a few months away
Due to the temporary leave of the current QA/RA Manager, the position of Quality Assurance and Regulatory Affairs is open for a period of 4 months. Your role involves the setting up of a QMS according to ISO13485 and FDA CFR 820. You will be the centre of the Quality related items, and your sparring partner will be the chief of development. You will also be involved in the ongoing development and improvement of the device.
This generalist function will also contain regulatory activities. 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.
- Setting up compliant QMS according ISO13485 - FDA CFR 820
- Formulating SOP and working instructions
- Being the Lead regarding the compliance for EC, UL, FDA
- Experience with DEKRA is a pre
- Technical, Medical, Engineering Bachelor
- Experience in QA Medical Devices - class 2/3
- 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