Regulatory Affairs consultant
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 Gelderland Netherlands.
This client is operating internationally. They are not responsible for the manufacturing or distribution of products, however they are supporting organisations in quality assurance procedures and regulatory affairs. They are rapidly growing and therefore, they are currently expanding their organisation.
ROLE DESCRIPTION
In your role as senior RA associate, you will guide clients, which are also operating internationally, with various procedures. You are a specialist who provides knowledge and expertise on: internal and external audits, RA including CE and FDA standards, Quality Assurance within the medical devices sector, and assessment/ improvement of procedures at the manufacturing site. In addition, you will also address necessary changes and adjustments of quality management systems in relation to required documentation. This role can be filled in for 6 months, with a possible extension to 8 months.
RESPONSIBILITIES
A major task as senior specialist, you will have to maintain relationships with our external stakeholders, which next to clients also include notified bodies and other authorities. Furthermore, your tasks on a daily basis include:
• Establishment and maintenance of relationships with clients whom you interact with on a daily basis
• Keep on track with the latest developments and changes on regulations and legislation, to be able to provide suitable advice to clients.
• Exchange of your knowledge and expertise towards Regulatory Affairs and other related topics for involved parties
• In addition, being well informed about developments for quality within the Medical Devices industry
REQUIREMENTS
• Bachelor in Life Sciences
• Minimal 6 years of experience within the Medical Devices sector in a RA role
• Knowledge of regulations and registration of products within Europe, America and China
• Strong communication and written skills
• Proven experience in advisory or supportive role
• Fluent in English
• Pro-active attitude and excellent organizational 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.
