Technical writer pharma/med dev
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 Pharmaceutical and Medical Devices organisation, based in Noord-Brabant Netherlands.
The CompanyMultinational in Pharmaceutical products.
Role DescriptionDays: For 2-3 days a week
Start date: ASAP
End date: minimum 30-JUN-2019 with possible extension to 31-OCT-2019 or 31-DEC-2019 depending on regulatory timelines
Freelancers are welcome!
Mission of the project: Move SaMD from MDD to MDR
ResponsibilitiesOur clients CE-marked SaMD (Software as a Medical Device) fall under the new Medical Device Regulation (MDR). We are looking for a specialist to assist in this global project.
Requirements• Background in regulated pharma environment with good understanding on regulatory and compliance requirement in software medical devices, and CE marking requirements
• Trained in ISO 62304
• Trained in MDD to MDR with a recognized regulatory body such as BSI, TÜV, NEN
• Technical writer with excellent documentation skills
• Affinity with requirement documentation needed for Design History file
• Good command of English language, verbal and written
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Arjan van der Schoor.