Experienced Regulatory Affairs coordinator

Location: Netherlands

SIRE 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 Noord-Brabant Netherlands.

Our client is a professional Healthcare and Medical Devices and operates at an international level. 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

On a daily basis you are involved with regulated standards, creating strategies for product launching, and involvement in regulatory submissions, concerning FDA, Health Canada , European and Asian regulations and legislation. You are involved with the regulations in relation to the product specifications, and required documentation. Furthermore, you are involved with product development and correct product registration on the various markets where to product will be launched. On a daily basis you will follow the latest changes and developments within the Medical Devices industry. This project is set for 4 months with possible extension to 6 months.

RESPONSIBILITIES

You will become part of an ambitious and high-technology environment. You are fully involved when it comes down to creating and developing an international strategy that covers all required legislation and regulations. Further responsibilities involve:
• Offering guidance regarding risk assessment and CAPA’s in order to meet the regulatory standards
• Taking the lead in creating an international regulations strategy involving CE-marking, product specifications and related legislation, and particular
evaluations
• Ensuring compliance for product launches and product registrations for existing and new markets
• Involvement and participation in development of business plans in which a regulatory point of view is required
• Establishment and maintenance of relationships with departments and external stakeholders on a global level

REQUIREMENTS

• Bachelor in Life Sciences
• Minimal 6 years of experience within the Medical Devices industry
• Minimal 3 years of experience in a strongly regulated environment
• Proven experience in process design and software development
• Excellent knowledge of American and European legislation and regulations
• Proven experience with 510k submission and coordination
• Fluency in English, and good understanding of the Dutch language
• Critical scope and excellent analytical skills
• Team player, yet individual operator

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.