Regulatory Affairs Cooperator

Location: Belgium

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 and Pharmaceutical organization, based in Brussel Belgium.

This company is a global market leader. Their mission is to improve health and to offer aid to those who have to deal with illnesses. Next to that, this client plays a major role in research and development of new treatments for cardiovascular and chronicle diseases, vaccines and cancer. Their mission is to save and support millions of lives.

ROLE DESCRIPTION

As a Quality Assurance Cooperator you will become part of a dynamic business setting in which everyone’s ultimate goal is to improve global healthcare. You will be part of a diverse, ambitious culture in which personal and company development are valued to create success. You will be a member of an essential team in which your main responsibility is the execution and maintenance of new product registration and legislation. Additionally, you will directly report to and assist the RA team leader, RA managers and the department director. This role lasts for half a year with possible extension for a couple of months.

RESPONSIBILITIES

As a team member, you will concentrate on the establishment of relationships with different counter parts of the organisation. Your knowledge and experience with Regulatory Affairs contribute to the overall business goals. Further tasks involve:
• Supportive and advisory role with team and team leader or managers. Together you are responsible for the overview of documentation and regulations
regarding new developed products on a national, MRP or DCP, and Benelux level.
• Approval and review of legal documentation in line with the vision of other business departments and external stakeholders.
• Additionally, correct implementation and control of processed data in line with these documents.
• Create awareness and understanding of changes and developments within Regulatory Affairs for both internal and external parties, or authorities.
• Maintenance of RA data in relation to entering data and management of documentation on a local, national and international scale.

REQUIREMENTS

• Master in Life Sciences
• Minimal 2 years of experience in legislation and regulations of the Benelux and Europe
• Knowledge and understanding of the Medical Devices market and its complexity
• 1 year of experience in building relationships with internal and external stakeholders
• Excellent skills in MS office package and automated management systems
• Fluency in Dutch, English and French
• Team player yet independent worker
• Problem solving 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.