Leveraging brain image analysis through machine intelligence

Quality and regulatory junior

Are you interested in quality management and medical device regulation? If yes, we are looking for someone to learn and grow with us. You will be involved in ensuring that our products meet the highest standards of quality and comply with the relevant laws and regulations. You will also have the chance to contribute as we are open to listen to everybody and you will help to build tensor.

Tensor Medical is a spin-off company of the University of Girona and the Vall d'Hebron Institute of Research (VHIR) in Barcelona with the main goal of helping clinical experts to improve care of patients suffering neurodegenerative diseases such as Alzheimer and Multiple Sclerosis (MS). At Tensor, we develop software that provides the most robust and precise medical imaging biomarkers to improve the clinical management of patients, to predict future disease stages and to optimize the treatment decisions for each patient.

We are a small remote-first startup that dreams big but always with a firm foot on the ground. Our team is composed of 10 members including medical key opinion leaders and internationally awarded medical imaging researchers. We are completely convinced that medical imaging biomarkers will revolutionize neuroradiology, so we are working on our mission to become the standard protocol in the clinical management of neurodegenerative diseases.

What are we trying to solve

Nowadays, we are focusing first on improving the clinical management of MS patients. MS patients are treated with different disease modifying treatments where their adherence is mostly based on the lack of brain Magnetic Resonance Imaging (MRI) activity (presence of new lesions) during periodic follow-ups. However, neuroradiologists quantify the presence of lesions by a tedious, time-consuming, and error-driven visual process that reduces their sensitivity below 50% in some cases, which can lead to sub-optimal treatments and increasing disability of the patient in the mid-term.

Although there are several automated solutions in the market that can deal with MS follow-up of MRI activity, still the latest international clinical guides published last year at the Lancet Neurology do not recommend the use of software solutions for MS follow-up mostly because of 1) the lack of evidence that these tools work in clinical settings and 2) the need of strict standardization of image acquisition (i.e., identical MRI system, pulse sequences, and acquisition parameters).

We are working to solve these issues, developing our deep learning-based software platform AH-1 that helps neuroradiologists to improve the assessment of MRI activity in MS patients, offering unprecedented sensitivity and specificity in detecting new appearing lesions.

Regulation plays a key role in all this. As a medical device software company we are highly regulated. We need to implement and keep up to date the applicable regulation and standards to our products and control all the process by establishing a quality management system. All this to ensure that we develop safe and high quality product.

Role description

We are looking for a new passionate member for our team who shares our vision who will help us on keeping the quality system and be in line with the applicable regulation.

This position aims to support the work of the quality department by assisting the quality manager in:

  • Devising and reviewing specifications for products or processes
  • Ensuring adherence to health and safety guidelines as well as legal obligations
  • Supervising inspectors, technicians, and other staff and providing guidance and feedback
  • Overseeing all product development procedures to identify deviations from quality standards
  • Inspecting final output and comparing properties to requirements
  • Keeping accurate documentation and performing statistical analysis
  • Soliciting feedback from customers to assess whether their requirements are met
  • Submitting detailed reports to appropriate executives
  • Preparing regulatory submissions and ensuring regulatory compliance with all relevant regulations and standards
  • Managing relationships with regulatory bodies, such as the FDA and CE notified bodies, and AEMPS
  • Participating in design and development activities to ensure that quality is built into products and processes
  • Filing appropriate compliance reports with regulatory agencies to work according to applicable regulations
  • Maintaining compliance and timely registration for licensing and products associated with the business
  • Developing and writing clear arguments and explanations for new product licenses and license renewals
  • Preparing submissions of license variations and renewals to strict deadlines
  • Managing quality documentation, such as standard operating procedures, work instructions, and quality records
  • Providing guidance and support to other departments to ensure that quality and regulatory requirements are met
  • Overseeing the appropriate training of all members of the company
  • Controlling and overseeing the post-market surveillance activities

We would love to meet you if you:

  • Care about our mission.
  • Like challenges and to question the status quo.
  • Have a bachelor degree in Engineering or related field.
  • Have knowledge or strong interested in medical device regulation and how to run a company with a quality management system that actually works for the company.
  • Are motivated and proactive with the ability to work independently, and develop and implement innovative ideas in an asynchronous remote team.
  • Have excellent written and verbal communication skills in English (Catalan and Spanish are a plus).

What can we offer you?

  • Full-time contract in an exciting international MedTech start-up environment.
  • Join a passionate team of high-performing members willing to improve patients’ lives, where everybody is trusted and has a voice.
  • Learn and grow together with the company in a challenging and fast-paced environment.
  • Opportunities to advance your career in a growing organization with an enriching culture.
  • Flexible working hours: work in a strong asynchronous remote team that is focused on tangible deliverables and results.
  • Competitive compensation according to your experience.

How to apply?

If you are already thrilled to know more and meet the position's criteria, we want to know you! Send us an e-mail to info@tensormedical.ai explaining to us why you want to join and attaching your CV.