Regulatory affairs new

The candidate will be a pivotal part of our team, responsible for registration and regulatory approvals of Methink’s products. Will also be responsible for grants, subsidies and quality control systems. The right candidate will have good analytical and writing skills, be willing to prepare appropriate documentation for different audiences, capable of solving problems in a startup environment, looking to improve health care in the world, and save lives!

We are looking for someone that can/has:

  • Understand and design regulatory strategy for our products
  • Prepare and maintain regulatory approvals, for CE Mark and FDA 510(k)
  • Experience in Quality Control systems (ISO 13485) and FDA QSR (21 CFR 820)
  • Ensure compliance with privacy regulations (GDPR & HIPAA)
  • Design and execute trials for regulatory approval
  • Write and maintain user manuals for our products
  • Experience in the medical device regulatory environment
  • Exposure the process of registering Software as a Medical Device (SaMD) would be particularly desirable; however, given the relative infancy of the Digital Health market, will also consider people with wider Medical Device experience
  • Prepare and follow-up of grants or government subsidies
  • None of the above but a good sense of humor and readiness to learn

Benefits/what we can offer:

  • Team: be part of a solid team with an extensive experience, passionate about their work and capable to bring cutting-edge technology to market.
  • Flexible work-life balance: we are focused in performance and everybody has different ways to achieve it. We make our best so that our colleagues feel comfortable in their work environment.
  • Progression: We are an early stage company with a multidisciplinary team. We offer the opportunity to people to grow together with the company.
  • Equal Employment Opportunity: We proudly pursue a diverse workforce and we don’t make any hiring or employment decisions that could be discriminatory in any way.
  • Benefits: Fee discount at a leading sports center in front of the sea, at a 15min walk from our offices.
  • Workplace: Pier01 in Barcelona, overlooking the Mediterranean Sea in Port Vell.
  • Annual compensation: 25k-40k + milestone bonus

If interested, please fill in the form: https://goo.gl/forms/Yuciyy47x0EgebK72 If you have any questions: This email address is being protected from spambots. You need JavaScript enabled to view it.

Deep learning developer

Will be an integral part of a small development team, responsible for research and development of deep learning systems for analysis of neuroimage. The right candidate will possess good analytical and programming skills, be willing to investigate and fail many times without despairing. Most importantly, you should have an appetite for creating new ways of solving problems, with artificial intelligence, applied in the real world, to improve health care in the world, and save lives!

We are looking for someone that can/has:

  • Understand the new way of programming using neural networks.
  • Read and keep up to date with related scientific literature
  • Guide and assist other development team members as part of a project team.
  • Work closely with technical leads to design development roadmap.
  • Work with neuroimaging tools to pre-process and post-process data.
  • Understand the medical implications of the diagnosing tools being developed.
  • Some experience/interest in Tensorflow/deep learning/machine learning.
  • Good capability to learn new software tools on his own.
  • Experience with python, numpy and pandas.
  • Some experience in image processing, transformations, filtering, etc.
  • Work with Amazon Web Services environment
  • The ability to setup, maintain and optimize Linux-based application servers
  • None of the above but a good sense of humor and readiness to learn

Benefits/what we can offer:

  • Workplace: Pier01 in Barcelona, overlooking the Mediterranean Sea in Port Vell
  • Annual compensation: $35K - $42K per year, and milestone bonuses.

If interested, please fill in the form: https://goo.gl/forms/zSimSovs6xLC4FgO2
If you have any questions: This email address is being protected from spambots. You need JavaScript enabled to view it.

View from the Methinks offices located just in front of the old port of Barcelona, 500m from the Barceloneta beach

Pier 1, Office 2D2

Plaça de Pau Vila

08039 Barcelona, Spain

info@methinks.es

CONTACT US!

Mo-Fr: 10.00 - 18.00 CET(Spain)