Senior Regulatory Affairs specialist EMEA
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.
They are a global leader with their dental devices and products. They operate, manufacture and distribute across the world and are with their innovative devices a fast paced and still growing company. They pride their self as a big organisation but not so big that you are not able to make an impact!
ROLE DESCRIPTION
They are now looking for a RA specialist to join the team where you will manage assigned product registrations. They vacancy is a new position in the organisation to create a proper regulatory strategy for new products and manage the appropriate processes, manage filing related activities and provide regulatory expertise on both internal and international issues.
RESPONSIBILITIES
The tasks and responsibilities that you will fulfill include:
• Managing registrations including Technical Files and filing determinations
• Prepare annual licensing renewal and product registrations
• Assist management in planning regulatory activities and projects and Develop regulatory strategies
• Provide guidance in complying with regulations
• Represent the Regulatory Affairs on project teams
• Establish Quality System procedures and policies for Regulatory Affairs and update as necessary.
• Review and approve document change orders
• Work with Quality, Engineering, and Marketing to ensure product supply
REQUIREMENTS
• Experience in Regulatory Affairs in Medical Devices or Pharma
• At least 3 years of experience in Regulatory Affairs
• Fluent in English, Turkish is a big plus
• Able to work well under pressure
• Able to work with international partners and therefore no 9 – 17 attitude
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
