Regulatory Affairs Specialist - Help with COVID-19

A global leader in medical devices and in vitro diagnostics is looking for a Regulatory Affairs Specialist to strengthen the EU Regulatory team. This company provides COVID-19 diagnostic kits on the international market so you can play a valuable part in this.

Another interesting project will be to assess impact and implement IVDR and MDR. You will work together with a big international regulatory team so you can bounce ideas and off each other and soak up the knowledge of the talented people around you. The business values the regulatory team which means that your voice will be heard and that even on a non-management level you will have contact with the international leaders of the company.

Responsibilities:

• Contact person for regulatory authorities and internal departments in EU region
• Compile the technical files
• Coordinate, review and respond to internal and external stakeholders in relation to regulatory documents and requests
• Develop and maintain procedures for regulatory activities and product registrations
• Manage projects and propose process improvements

Requirements:

• Master Degree or PhD in Life Sciences
• First experience in Regulatory Affairs for the Medical Device or Diagnostic industry
• Knowledge of MDR and/or IVDR is ideal
• Strong knowledge of regulations on EU level
• Fluent level of English

Benefits:

• Long-term indefinite contract
• Market conform salary with extra benefits
• Structured and organized company where you can see a growth plan and career development
• Easily accessible by public transport
• Home based flexibility

If this job appeals to you please apply here or on the NonStop Consulting website or send it to me, Annelies De Baere, on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.