RA & QA specialist region of Antwerp
Location: BelgiumSIRE 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 Belgium.
This client is specialised in giving advice and recommendations on regulatory affairs and quality for Medical Device and IVD developers on a European scale. Their goal is to deliver pragmatic applicable plans to enlighten the pressure on QA and RA for organisations that have to cope with multiple European countries. They offer guidance throughout the entire process, from the beginning to the end.
ROLE DESCRIPTION
You will become part of a continuously developing business setting where you are able to expand your knowledge and evolve your skills in Regulatory Affairs and Quality Assurance. You will have a supportive role for worldwide manufacturers in medical devices that are active within the European market. You will be a representative for the organisation’s customers which involves the maintenance and establishment of relationships with external stakeholders. You are the contact person for companies that have trouble in finding answers and solutions for RA or QA related topics. This role can be filled in for 3 months with a possible extension to 5 months in total.
RESPONSIBILITIES
As mentioned previously, you are the contact person of the client’s customers, which gives you various responsibilities, among which:
• Assistance in controlling companies’ regulations and legislation in line with their product specifications
• Identification of missing documentation and quality standards for a particular organisation
• Being the first point of contact during the implementation and adaption of quality standards and regulations
• Offering advice and guidance when it comes down to the organisation’s Quality Management System
• Helping out whenever there are particular misunderstandings or gaps of knowledge in relation to the ISO 13485 standards
REQUIREMENTS
• Bachelor in Life Sciences
• Minimal 6 years of experience in the Medical Device sector
• Minimal 4 years of experience within a QA and RA role within Medical device company
• Excellent knowledge of In Vitro Diagnostics
• Fluency in English and Dutch, and business level understanding of French
• Pro-active attitude and problem-solving skills
• Extraordinary communication skills
• Team player
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.
