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!
The companyOur client is a professional Medical Devices organization, based in Brussel Belgium. They are a developer, manufacturer and supplier of diagnostic products, medical imaging systems and surgical products and with that an international leader with their products in the Device industry. Currently they are looking for a new RA Manager to manage and coordinate the Company to Regulatory compliancy to distribute their products.
Role descriptionThe new RA Manager will have a central position in the company, managing his/her own team and working together with the QA Manager/team to guarantee compliancy with all local and international regulations. You will be responsible over the EMEA region from Brussels. The Management position is expected to grow to Director level on short term (1 – 2 years) To play a support role for the current CEO and manage more on a higher level within the company.
ResponsibilitiesYou will work together/coordinate and coach the RA team to become/stay compliant with the new Medical Device Regulations. This will include training your team, hiring/recruitment of new RA (and in cooperation QA) employees, performance evaluation and coordinate performance of the team.
You will be responsible for all RA processes and activities, Documentations, Technical Files, Registrations, Submissions and new projects/product launches, etc..
Requirements• At least a Bachelor degree
• A minimum of 7 years RA experience with at least 3 years of experience in Medical Devices
• Working knowledge of QA and RA processes within a Medical Device environment
• Working knowledge of RA processes including submissions and registrations of new products, Documentations, Technical Files, being in contact with (local) authorities and audits.
• Experience of submissions and registrations in Asia and America is a big plus
• Understanding of ISO 13485 and/or FDA 21 CFR part 820 is a big plus