Regulatory Affairs Specialist

Job description

WHY WE NEED YOU

NICO.LAB Is a young Innovative company that requires a Regulatory Affairs Specialists to expand Its market reach by getting regulatory approval for its expanding groundbreaking product portfolio of AI-powered software solutions for stroke diagnosis.

Through your drive for performance, it will be crucial to find the right regulatory strategy for different regulatory markets. Through your constant internal communications and eye for detail, you will assemble and create the required technical documentation for ensuring compliance of our products to regulatory requirements.


WHAT YOU'LL DO:

  1. Upgrade our current CE certifications under MDD to MDR and drive certification for our new biomarkers of our AI-powered software solutions for stroke diagnosis.

  2. Facilitate regulatory approval of our products in markets outside of the EU in the USA, Australia and others.

  3. Assemble technical files for our products according to regulatory requirements

  4. Develop a regulatory strategy for new markets and products

  5. Maintain regulatory compliance of our product portfolio In various markets



Job requirements

WHAT YOU’LL BRING

Flawless understanding of international and market-specific (FDA, CE, TGA) regulations. regarding medical devices. You'll prepare Technical Files for medical devices in different markets. You have experience with CE certification of medical devices under MDD but preferably MDR. In addition, you bring regulatory experience with software as a medical device and regulatory experience with FDA requirements & submissions for medical devices. We appreciate your interest In processes outside your own direct work area.


WHAT WE'RE LOOKING FOR:
  • Regulatory experience with Medical devices in Europe, the US or other parts of the world such as Australia

  • Bachelor of Science, Medicine, Engineering, or other relevant fields

  • Personal drive to get things done and manage your tasks

  • Excellent English language skills (written and oral)

  • Excellent attention to detail and quality

  • Editorial/proofreading skills


WHAT WE OFFER:

  • Chance to make a real difference in patient’s lives
  • Pension contribution
  • Additional 8% holiday pay
  • Flexible working hours
  • Travel expenses by car, train or bike
  • Work laptop (Apple or other)
  • Free lunch 
  • Stimulating environment with a fun motivated team

WHO WE ARE:

We believe the combination of artificial and human intelligence will revolutionize emergency care and we work each day to make that happen. Founded in 2015 as a spin-off from the Amsterdam University Medical Center, our research background continues to drive our way of thinking. We have a diverse team from all corners of the world, composed of researchers, developers and experienced medical specialists who ensure our product and services match our clients' needs. We’re first tackling the major issue of stroke, the leading cause of life-long disability, where we will ensure every patient gets the right treatment in time. Watch more here.