Medical Device Software Validation Specialist

Job description

WHY WE NEED YOU:

At Nicolab, we believe connecting human and artificial intelligence will revolutionize emergency care. We develop end-to-end solutions to further empower physicians in emergency care. We are growing globally and therefore looking for a Medical Device Software Validation Manager who will strengthen the regulatory team.

You will manage and perform software validation, clinical evaluation projects, and technical documentation preparations of our medical device algorithms for clearance in the EU, USA, and worldwide. Your work will be critical for our efforts to make our comprehensive software solutions for stroke care available for healthcare professionals all over the world, enabling them to give the best treatment to patients suspected of stroke.


WHAT YOU'LL DO:

  • Collaborate with AI engineers to ensure adequate technical validation of our algorithms

  • Write software validation documentation

  • Collaborate with medical and science team to plan clinical evaluations

  • Collaborate with the engineering team to set up infrastructure for clinical evaluations

  • Manage clinical evaluations projects with internal and external stakeholders

  • Write clinical evaluation documentation

  • Manage the compilation of technical files

  • Prepare medical device submissions following regulatory requirements


Job requirements

WHAT YOU’LL BRING

You have a passion for medical device software validation and clinical evaluation to bring our AI-powered products to the market that help health care professionals worldwide to make the best decisions for their patients suspected of stroke. You have working experience in medical device software validation and clinical evaluation and thrive in a complex and diverse environment where you can align the expertise of colleagues from different departments and backgrounds for the best results. You have a scientific and systematic approach to solving problems. 


WHAT WE'RE LOOKING FOR

  • 2+ years of experience in the same or similar position in the SaMD industry

  • Ph.D. in Bioinformatic, Bioengineering, Medical AI, Medical Informatic, Technical Medicine or equivalent field or master with 5+ years of experience in SaMD industry.

  • You have project management skills and experience

  • Knowledge and experience with ISO 13485, ISO 62304, and ISO 14155 are ideal.

  • Knowledge and experience with regulatory requirements for medical device software according to MDR, FDA, and requirements in other regions are preferred.

  • Communication skills, written and oral, in English.


WHAT WE OFFER:

  • Chance to make a real difference to patient’s lives

  • A fun and ambitious work environment

  • Pension contribution

  • Additional 8% holiday pay

  • Flexible working hours

  • Travel expenses by car, train or bike

  • Work laptop (Apple or other)

  • 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.