Regulatory Affairs Officer
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 Netherlands.
Our client is a medium sized and growing developer and producer of medical devices within different therapeutical areas from cardiology to oncology.
ROLE DESCRIPTION
In this role you will work within the QARA department and hold contact to different stakeholders within and outside the company. Furthermore you will help to develop the Quality System and prepare audits.
RESPONSIBILITIES
- Keep contact with contact partners from regulatory institutions and notified bodies
- Take part in maintaining and developing the Quality System
- Take part in ensuring accordance to ISO 13485 and MDD
REQUIREMENTS
- Very good knowledge of ISO 13485 and MDD
- B.Sc in natural sciences
- Minimum of 3 years in QA
- English and Dutch fluent
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robin Krems.
