Specialist in EU & US Regulatory Affairs
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 Noord-Holland Netherlands.
This market leader is determined to improve healthcare on an international scale. This organisation possesses a broad range of qualified, highly innovative, technological products and services. Their products are distributed among 100 countries.
ROLE DESCRIPTION
In your role as RA expert, you are responsible for the planning, coordination and implementation of strategic approaches and related activities in relation to the development of new products and approval to launch these products. You are responsible to control and maintain the European and American Medical Device regulations and procedures. This also requires knowledge and understanding of safety principles and standards applicable to their products. You will be interacting with the production site on a daily basis to ensure that European and American regulations and legislation will be implemented. Furthermore, you will be a mentor in advising departments. You can fill in this position for minimal a year with the possibility to fulfill this role another year.
RESPONSIBILITIES
You will gain authority in documentation and overview the compliance of required documentation and legislation both for existing products and newly developed products. Furthermore you will have:
• A supportive role in relation to regulatory affairs for the Research and Development department and production site
• Establish and maintain a relationship with competent authorities, notified bodies and FDA, and other qualified agencies
• Development and practice of trainings derived from discrepancies from the workfloor and field
• Creating awareness among internal and external stakeholders for the importance of Quality and Regulatory Affairs
REQUIREMENTS
• Master degree in Life Sciences
• Minimal 4 years of experience with RA in Medical Devices sector
• Excellent knowledge of EU and US regulation and regulation concerning Healthcare industry
• 2 years of experience in collaboration with notified bodies and authorities
• Excellent skills in applying European standards to company products
• Strong communication skills
• Fluency in English and Dutch
• Extraordinary analytical skills
• 2 years of experience in mentor and leadership role
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.
