Project Engineer Regulatory Affairs
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 Biotechnology, Medical Devices and Pharmaceutical organization, based in Zuid-Holland Netherlands.
The company is specialized in developing and manufacturing surgical equipment for the international industry.
You will be responsible for project and specific project with regards to the development of new products and product improvements. You will be part of the projectgroup and will be responsible for delivering all documentation necessary for the Technical Dossier of the product.
- Delivering documentation compliant to regulations in the Medical Devices industry
- Take care of the documentation regarding the design of the product and manufacturing
- Composing test methods. verification, and validation protocols and reports
- Product characterization
- Carrying out FMEA
- Composing reports on Clinical Evaluations
- Purchasing of materials and molds
- Reporting to Manager New Product Development and Project Manager
- Working closely together with various departments within the company
- Applied Sciences in Mechtronics or Precision Engineering
- Minimum of 3 years experience in Manufacturing Environment
- Knowledge of Medical Devices
- Knowledge of ISO 13485/MDD regulations
- Ability to solve difficult cases in theory and with best practices
- Knowledge of Risk Management, MS Office, Visio and ERP
- Impeccable knowledge of Dutch and English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Onno Goedhart.