In the role of Quality Assurance & Regulatory Affairs Specialist, you are the person who guarantees the quality of the products produced by this client.
For this role it is therefore important that you have a strong personality and have analytical skills with which you can collect the right information. Are you the person immediately available for this fulltime employment ? Then continue reading!
The Quality Assurance & Regulatory Affairs Specialist performs various checks on medical devices before they are released on the European market. Therefore, it would be a big plus if you already have experience in the medical device industry. Before products enter the market, it is important that all necessary documentation is properly completed, documented and submitted. Once the products are on the market, it is your job to keep track of the document management system and manage the registrations made in both national and European databases.
Because it is important that this is done accurately and correctly, we expect you to work according to a flawless working method.
Furthermore, you support the Regulatory Affairs Manager Europe and the customer in their activities. You will also be actively involved in the operation of plans to ensure compliance with regulations that affect the company's activities. With your fresh perspective and creative ideas, you will help develop strategies to ensure regulatory compliance.
You will work closely together with other departments within this organisation to ensure the highest possible quality at all times. It is your responsibility to make sure all relevant information is shared within those departments.
Wie ben je?
Preferably you have a bachelor degree in Laboratory Technology, Medical Biology, Medical Technology, Chemistry, Pharmacy. A master's degree is an advantage
You're fluent in both verbal and written English. You have an advantage if you also speak and write Dutch;
You have at least 2 years of experience in a quality management system;
Regulatory experience preferred;
You're highly proficient with the programs of Microsoft Office;
You know how to deal with a high workload and the deadlines to be achieved.
Over het bedrijf
As a leader in global healthcare, their goal is to create and develop products that preserve and enhance lives. A fundamental focus of this goal is ensuring that their products are safe and effective, and that they deliver the intended benefits.
This client is a global player in the field of health and strives to give people not only a longer, but also a better life. Approximately 94,000 employees in 150 countries worldwide work on a diverse portfolio of diagnostics, medical devices, nutrition and medicines. At this organisation you have the opportunity to make a positive impact on the world in a challenging job with added value.
Wat bieden wij jou?
A competitive salary based on education and work experience ( between €38700 and €58000 gross per year);
Your growth would be supported through extensive training opportunities;
Your contributions are recognized and rewarded through market-based compensation, linking your work to the success of the company;