Quality & Regulatory Affairs Director
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 Healthcare and Medical Devices organization, based in Netherlands.
Our client is a professional Healthcare and Medical Devices organisation located in the Netherlands. They are one of the leaders in technological developments and innovation. They are active within a broad range of technology-driven industries, varying from household products to healthcare devices.
ROLE DESCRIPTION
As a director you will have a corporate role. Therefore, our client is looking for a professional with a hands-on mentality and a proactive attitude. Part of your daily job is to create awareness for quality and regulations among employees from various departments. Next to that, you will maintain, implement, and apply changes within their quality systems. Furthermore, you will need to connect these systems to their digital platforms. Therefore, the Software and Hardware standards and regulations must be followed. You will work in a dynamic business setting as you work from two locations. Our client offers a valuable project for 6 months (extension is possible) which gives you a great opportunity to develop your technological and leadership skills!
RESPONSIBILITIES
As a director you will direct a team of 7 experienced employees located within the Netherlands and India. As you are responsible for Quality and Regulatory Affairs, you should have good knowledge of European, American and Canadian Regulatory Affairs. Other responsibilities you will receive:
* You will play a major part within internal and external audits.
* You will carefully analyse the outcomes of these audits and identify to discrepancies.
* You will build up relationships with other Quality Assurance professionals across the organisation to find the best practices.
* You will focus on the organisation’s external environment to identify changes and developments which will be valuable to the organisation.
REQUIREMENTS
* Bachelor of Science
* 6-10 years’ experience in the medical devices industry
* Good knowledge of Quality and Regulatory Compliance
* Evidence of leadership capabilities
* Good knowledge of FDA and word-wide regulations
* Experience in software and security control systems
* Fluent 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.
