Regulatory Affairs & Quality Control operator
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 Limburg Netherlands.
This organisation particularly focuses on selling natural wound care products. They focus on innovation and creation of a broad international platform. They are exploring their position in the market and are aiming to increase their market share, therefore there are looking for new employees.
ROLE DESCRIPTION
In your role as Quality Control and Regulatory Affairs officer you will be responsible for the launch of new products. You will become part of a dynamic and innovative business setting, that prioritises to protect the environment and nature. Additionally, you are involved with required legislation and documentation. You will be reporting directly to the operation manager. Furthermore, you will be involved with the Quality Management System and ISO standards. This project is set for 5 months with possibility for extension to 8 months.
RESPONSIBILITIES
As mentioned previously you will be focusing on both QC and RA. Your major task involves compliancy and control of product specifications. Furthermore, you are focusing on:
• Maintenance of the Quality Management System and identifying points of improvements
• Responsible for product launch and compliant product specifications
• Follower of the latest developments and changes within international and European legislation and Quality standards
• Controlling and adjustments regarding international legislation and regulations among which the CE-marking standards
REQUIREMENTS
• Master in Life Sciences
• Minimal 3 years of experience in the Medical Devices industry
• Minimal 2 years of experience in Quality Control roles
• Practical experience with ISO 13485 and Good Manufacturing Practice
• Excellent knowledge of European regulations
• Excellent communication and writing skills
• Fluency in Dutch and English
• Extraordinary organizational and analytical skills
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.
