Interim Quality Assurance & Regulatory Affairs Manager
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 technology driven and focuses on creating tools for the quality control of In-Vitro Diagnostic products. Innovation is key for this organisation in order to fulfil the needs and demands of their customers. Therefore, they decided to expand their organisation.
ROLE DESCRIPTION
As RA and QA manager you will guide a small team of professionals. On a daily basis you will be interacting with the manufacturing and distribution site. You will advise the manufacturers and other involved parties to distribute the products correctly. In addition, you are the person of contact for external stakeholders among which international authorities. Furthermore, 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. This project is set for 3 months and can be extended to 6 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:
• Overviewing the ongoing changes and points of improvement for the Quality Management System and relevant, required documentation
• Supportive and advisory role as team lead, and for subsidiaries of the organisation
• Establishment and maintenance of internal and external relationships
• Creating awareness and spread of knowledge regarding QA and RA related topics and procedures
• 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 4 years of experience in an strictly regulated environment
• Minimal 3 years of experience with QA on a production site within the Medical devices industry
• Evidence of leadership experience and organizational skills
• Fluency in Dutch and English
• Strong communicator
• Experience in working with notified bodies and other authorities
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.
