Regulatory Affairs Associate
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 Zuid-Holland Netherlands.
This organisation is active in the ophthalmology sector and aims to work directly with hospitals. This close collaboration enables the company to evaluate and improve their products immediately in need of their clients. This guarantees rapid development and high- quality products.
ROLE DESCRIPTION
In your role as RA specialist, you will gain the responsibility to collect, maintain and adjust technical files and relevant documentation. In addition, you interact with internal and external stakeholders and you will ensure that they are provided with the required information. You will have a supportive role in creating awareness and exchange of knowledge about international regulations and changes. Next to that, you are involved in the development of strategic plans which are related to the Regulatory Affairs and the implementation. This project is set for 6 months with a possibility to extension.
RESPONSIBILITIES
On a daily basis you are responsible for the collection and implementation of regulations in relation to the specification of various products. Furthermore, your tasks include:
• Active role in maintenance and (new) product registration for particular foreign markets
• Development and adjustment of strategic plans and assessment of procedures for verification and validation projects
• Supporting execution of evaluation and risk management procedures
• Supportive role for both internal and external stakeholders about RA related topics
• Development and assessment of the documentation database
• Application and implementation of international legislation and documentation
REQUIREMENTS
• Bachelor in Life Sciences
• Minimal 5 years of experience in a RA role within the Medical Devices sector
• Excellent knowledge of ISO 13485, particularly the 2016 norm
• Excellent knowledge of the Medical Device Directive
• Excellent writing and verbal skills in English and Dutch
• Strong analytical skills and eye for detail
• Pro-active attitude
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.
