We are the global leaders in clinical Conversational AI in healthcare. Genuinely! Our product, THM, is the only patient management platform with a CE-marked for AI clinical phone conversations for different pathologies and care processes. Safe and clinically validated.

Today, we operate in 3 countries and we’re improving tens of thousands of patients lives in more than 30 different care pathways. We partner with the best healthcare systems and life science companies to transform patient care and augment healthcare professionals capacities.

We have received numerous awards, including €5.5M funding from the European Innovation Council.

We’ve been doubling the team year over year to keep up with our growth. So if you want to be part of a company transforming how patients receive care, just keep reading!

**CONTEXT

The need for a** Quality Assurance and Regulatory Affairs (QARA) Technician arises from several factors within our current operational landscape and future growth:

• Currently, we are undergoing the certification process for our medical device software in accordance with the Medical Device Regulation (MDR) and also for ISO 13485. This includes managing the quality management system, analyzing customer complaints, overseeing change management processes, and conducting post-market surveillance activities. On the other hand, our product involves software components that require maintenance and adherence to regulatory standards. Tasks such as analyzing the impact of software changes, conducting verifications, and usability studies are essential for maintaining regulatory compliance and product integrity.
• Regarding security, we are certified in ISO 27001 and National Security Scheme, which requires maintenance.
• International Expansion: With our product currently available in Spain, Portugal, and the UK, and plans for expansion into the US market, the regulatory landscape becomes increasingly complex.

A QARA Technician is essential for maintaining regulatory compliance, quality standards, and facilitating future growth.

WHAT YOU’LL DO

During the first weeks, you’ll delve into our QMS processes and how our product works.

As you know the basis on ISO 13485 and MDR -ideally medical device software- you’ll work with Clara, our QA/RA Lead and together you’ll be preparing tests for the new requirements, analysing the changes, verification of new implementations in customers, etc.

After some weeks, you’ll be involved in more QMS processes as: post-market activities, CAPAs, but also on product documentation: maintenance of the Technical Documentation.

Over time, you’ll take responsibility in some processes and you’ll be able to work autonomously on new projects and ****challenges we’ll face.

RESPONSIBILITIES

The person who joins the team will be involved in the following activities:

• Maintain our quality management system (QMS) in compliance with relevant standards and regulations.
• Participate in the software sprint planning: help the team in identifying, assessing, and mitigating risks related to our medical devices, while also overseeing the maintenance of the Risk Management File, define tests and evaluation of software changes, including end to end testing. Assist in the performance evaluation of AI algorithms.
• Participate in internal and external audits.
• Take charge of the CAPA process, including the detection of non-conformities, root cause analysis, and the execution of corrective and preventive actions.
• Suppliers evaluation.
• Participate in post-market activities analysis.

Moreover, you’ll provide support on:

• the Technical Documentation preparation and updates according to the Medical Device Regulation: requirements, descriptions, risks, whatever is needed!