Regulatory Affairs Consultant
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 Genf Switzerland.
Medical Device company with a very innovative portfolio of Class III devices (Infiltration syringes and tubes).
Due to a letter from the notified bodies, the company needs to update their Regulatory DHF history file.
Other relevant information:
- Starting date: ASAP (it is urgent)
- Availability: full-time
- Work remotely: 1 - 2 days are required to be on site
- Duration: 3-6 months (the project is for 1 specific file)
- Update/ Modify the Regulatory DHF history file
- Support in the certification of the CE Marking
- Revise the clinical studies and evaluations
- Writing the clinical/ regulatory file
- Support the team in the communications with the notified bodies
- Strong scientific background
- +5 years of relevant working experience in Regulatory Affairs in Medical Devices
- Ability to work independently without much supervision
- Preferably experience with plasma products
- Language skills: English (French appreciated)