A.I. Regulatory Affairs & Quality Assurance 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 Noord-Holland Netherlands.
This client is an international market leader with the aim to improve lives by the development of advanced cancer diagnostic systems and devices. They are represented in over 100 countries and are still expanding their business.
ROLE DESCRIPTION
As an A.I. QA and RA manager you will become part of an ambitious and innovative environment. You are in charge of a team consisting of specialists with different disciplines: QA, RA and QC. In collaboration with your team, you will make sure that the QMS is compliant and that all required documentation is controlled, involving variations of legislation for particular product specifications. On a daily basis you are responsible for overviewing the Quality and Regulatory strategies and procedures. You will be involved with international procedures and market strategies. You will assist in creating company strategies and exchange your knowledge across other departments within the company. This role for interim manager can be filled for 8 months with the opportunity for extension to a year.
RESPONSIBILITIES
Overall, you will be in charge of the Quality Assurance, Regulatory Affairs and Quality Control activities. You will guide and direct your team. Furthermore, your responsibilities involve:
• Development and improvement of the Quality Management System
• Collecting and overviewing all required documentation and legislation for national and international markets
• Key contact person and representative for Quality and Regulatory matters such as 21 CFR 820, ISO 13485, ISO 9001, and MDR
• Tracking and controlling the KPI’s and the performance of the department
• Creating awareness in- and outside the organisation concerning RA, QA and QC topics
REQUIREMENTS
• Bachelor in Life Sciences
• Minimal 7 years of experience in a QA role within the Medical Devices industry
• Minimal 4 years of experience in a strongly regulated environment
• Evidence of leaderships and organisational skills
• Excellent knowledge of US and European quality standards and regulations
• Experience in projects with In-Vitro Diagnostics
• Excellent communicator
• Fluency in English and Dutch
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.
