Manager Regulatory Affairs & Quality Assurance IVD
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 Gelderland Netherlands.
This organisation is specialised in creating tools to control the quality of IVD equipment. These materials are made precisely and with very specific knowledge. They are innovative, and technology driven. Their products are highly valued for organisations in IVD equipment, and therefore they are looking to expand.
ROLE DESCRIPTION
In your role as Regulatory Affairs and Quality Assurance manager you will be in charge of a small team of professionals. On a daily basis you will be interacting with the manufacturing and distribution site. In addition, you are the person of contact for external stakeholders among which international authorities. You will assist in the launch of new products when it comes down to check whether product specifications are in line with the required legislation and quality standards. Additionally, you will also advise the manufacturers and other involved parties to distribute the products correctly. This project is set for 4 months and can be extended to 8 months.
RESPONSIBILITIES
As QA/Ra manager you are the representative of the organisation when it comes down to Quality Assurance and Regulatory Affairs. Next to that, your responsibilities involve:
• Supportive and advisory role as team lead, and for subsidiaries of the organisation
• Creating awareness and spread of knowledge regarding QA and RA related topics and procedures
• Overviewing the ongoing changes and points of improvement for the Quality Management System and relevant, required documentation
• Establishment and maintenance of internal and external relationships
• Key contact person concerning Quality Assurance and Regulatory Affairs for internal and external stakeholders among which authorities and notified
bodies
REQUIREMENTS
• Bachelor of Science
• Minimal 3 years of experience in an strictly regulated environment
• Minimal 2 years of experience with QA on a production site within the Medical devices industry
• Evidence of leadership experience and organizational skills
• Great eye for detail and strong analytical skills
• Experience in working with notified bodies and other authorities
• 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.
