Quality Assurance and Regulatory Affairs associate
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 Utrecht Netherlands.
This organisation provides In-Vitro Diagnostic tests and services. They started about 10 years ago and as they have established their position in the market which resulted in a growth of the company, and are therefore looking for additional support.
ROLE DESCRIPTION
As an associate you are primarily responsible for the maintenance and the development of the Quality Management System in relation to compliancy of the ISO 13485 quality standard and international and national legislation and regulations. You will have a supportive role when it comes down to the development of new products and with a special focus on the relevant documentation and legal principles. You will take the lead in the submission and exchange of files for internal and external stakeholders. Furthermore, you are involved with particular procedures and you will give advice about QA and RA related topics. You will be a representative for authorities and notified bodies. This role is set for 6 months and can be extended to 8 months.
RESPONSIBILITIES
On a daily basis you are generally focusing on the maintenance and improvement of the Quality Management System. Additionally, you will overview and control all legal documentation that is related to the company’s products. Further responsibilities include:
• Overviewing and controlling quality standards and principles in relation to the company’s products
• Preparation, registration and coordination of technical files and updates of submissions where necessary
• Key contact person for internal and external authorities among which notified bodies both for Regulatory Affairs and quality standards
• Taking the lead in audits and guiding the process from the beginning to the end
• Pro-active approach in finding CAPA’s
REQUIREMENTS
• Bachelor in Life Sciences
• Minimal 3 years of experience within a QA role in a Medical Devices industry
• Minimal 1 year of experience in a strongly regulated environment
• Excellent knowledge of ISO 13485 and relevant documentation
• Team player, yet individual operator
• Experienced with the establishment and maintenance of relationships with external stakeholders
• Great eye for detail
• Fluency in 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 Juliette van Kraaij.
