Regulatory Affairs Specialist: world leader of Medical Devices

Our client, a global leader in medical devices and in vitro diagnostics (IVD) is looking for a Regulatory Affairs / RA Specialist to strengthen the EMEA Regulatory team. 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.

The first main focus and interesting project will be to assess impact and implement IVDR and MDR. Next to that, you will also help to put a COVID-19 diagnostic on the international market which is quite exciting that you can play a part in this. 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.

Responsibilities:

• Contact person for regulatory authorities and internal departments in EMEA 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
• Several years of experience in Regulatory Affairs for the Medical Device or Diagnostic industry
• Knowledge of MDR and/or IVDR is ideal
• Strong knowledge of regulations on EMEA level
• Fluent level of English

Benefits:

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

You can contact me (Michael van Hooft) at:

m.hooft@nonstop-recruitment.com

or call me at +32 (0)2 891 98 99 with extension number 3147

You can also visit our website at: www.nonstop-recruitment.com for more awesome career opportunities.

NonStop is one of the largest and fastest growing specialised life sciences 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 and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.