Full-time position OPEN - ideally in the UK, can be remote or at Tallinn HQ

Who we are

Healthy Networks is a digital health brand developing smarter technology for respiratory care.

We firmly believe in the positive outcomes of a consumer-led healthcare system. This is why our flagship product, LungPass smart stethoscope, has been designed for home use. It's an intuitive, precise and affordable device that over a thousand of families already rely on to automatically differentiate between dangerous lung conditions and mild ones.

https://www.youtube.com/watch?v=fSBLXNyJHog

We're a 15-people strong team of product developers, data scientists, and medical professionals driven by the desire to change the access to affordable diagnostics on a global scale. We're backed by an extended network of respiratory experts, venture capitalists, and business execs who put multiple successful healthtech products on global markets.

LungPass is gaining traction in CIS. For our plan to make our product available worldwide, we are looking for impact-driven healthtech pioneers to join the team.

The role

As a Senior Quality Assurance and Regulatory Affairs Specialist at Healthy Networks, you will be a key partner to our CEO and co-founder Helena in bringing LungPass to new markets and expanding its claims. You will be the principal person responsible for maintaining and improving existing RA and QA processes, as well as developing new ones.

The company is ISO 13485 certified. The product is registered in CIS as an OTC medical device. It is also registered with the FDA for Rx use by professionals.

Why join

• Help make precise and intuitive respiratory care accessible to people around the world
• Be at the forefront of the rising digital health field
• Grow into the Head of QA/RA Officer position and build up your own team in due course

Your key tasks and responsibilities

• Propose and maintain regulatory plan in accordance with the company's commercial objectives
• Ensure products are cleared to the appropriate markets as per regulatory plan and manage regulatory maintenance in existing territories:
  • this includes writing up relevant documents for submissions, generating and maintaining instructions for use and labelling for all products, communicating with FDA / NBs, etc.
• Take responsibility for the ongoing maintenance and continuous improvement of the QMS to ensure compliance to EN/MDD/MDR, ISO 13485 and FDA requirements
• Proactively manage company-wide business processes to ensure product and service quality:
  • this includes oversight of software and firmware development process in accordance with IEC 62304.
• Oversight of development and maintenance of the risk management in accordance with ISO 14971