Regulatory Affairs & Quality Assurance cooperator
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 Zuid-Holland Netherlands.
This organisation is responsible for the development, manufacturing and the sales of a specific medical device product. Their clients vary from hospitals to distributors. Currently they are experiencing and extensive growth and therefore they are looking for support.
ROLE DESCRIPTION
You will become part of a dynamic and innovative business setting, where you will be responsible for support on the improvement and maintenance of the QMS. Additionally, you are involved with required legislation and documentation for which you make sure that all documentation is controlled and implemented. Furthermore, you will be involved with the Quality Management System and ISO standards. On a daily basis you will work with SOP’s, the MDR, and the MDD. You will closely collaborate with the QA & RA manager. This project is set for 5 months with possibility for extension to 8 months.
RESPONSIBILITIES
On an daily basis you are mainly involved with Quality Management System and related documentation and required legislation. Further, responsibilities involve:
• Maintenance of the Quality Management System and identifying points of improvements
• Complaint handling and execution of CAPA’s
• Support and guidance of audits from the beginning to the end
• Making reports and giving advice about regulatory and quality issues
• Controlling and adjustments regarding international legislation and regulations among which the CE-marking standards
REQUIREMENTS
• Master in Life Sciences
• Minimal 3 years of experience in the Medical Devices industry
• Minimal 2 years of experience in Quality Control roles
• Excellent knowledge of European and international regulation
• Practical experience with ISO 13485 and acting up on the Medical Device regulations
• Excellent communication and writing skills
• Fluency in Dutch and English
• Extraordinary organizational and analytical skills
• Eye for detail and problem solving skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.
