QARA Specialist
At Tucuvi, we help healthcare organizations ensure every patient receives timely high-quality care by augmenting clinical teams with AI. Our clinical-grade AI Care Management platform automates and orchestrates high-volume workflows end to end, combining autonomous AI agents with workflow logic, escalation, documentation, and integration into existing health system infrastructure. Tucuvi is the first Class IIb Software as a Medical Device (SaMD)–approved AI platform for Voice AI driven patient management.
CONTEXT
We have built the first Clinical AI Agent certified as Software as a Medical Device (SaMD) under the EU Medical Device Regulation (MDR), with CE marking and ISO 13485 certification. As we scale across Europe and the US, maintaining a rigorous Quality Management System (QMS) is non-negotiable. The QA/RA (Quality Assurance & Regulatory Affairs) team is central to ensuring safety, quality, and regulatory compliance.
WHAT YOU'LL DO
Your main mission will be to own the day-to-day operation and continuous maintenance of Tucuvi's Quality Management System, ensuring compliance with ISO 13485 and the EU Medical Device Regulation (MDR). You will maintain and improve the QMS as the product and organization evolve, ensuring processes are documented, changes are controlled, and requirements are met.
- QMS documentation maintenance: Draft, update and release SOPs; manage document control and ensure proper communication and reading confirmation across the team.
- Supplier management: Lead periodic evaluation of QMS-related suppliers and keep records in line with ISO 13485.
- Deployment control: Support and coordinate quality control for new Work Unit deployments, ensuring proper validation and documentation.
- Audit participation: Participate in internal and external audits, prepare evidence, coordinate teams, and follow up on findings.
- Regulatory compliance monitoring: Conduct periodic reviews of the regulatory compliance plan and ensure alignment with MDR and ISO 13485.
- QMS software validation: Generate software validation reports for QMS-related tools in compliance with regulatory standards.
- CAPA management: Manage the full lifecycle of Corrective and Preventive Actions from identification to closure and effectiveness review.
- Data analysis & reporting: Analyse quality data and prepare reports to support management reviews and decision-making.
- Product & tools QA testing: Conduct manual QA testing of products and internal tools when required.
WITH WHOM YOU WILL WORK
Remote-first company; you will work closely with the QARA team and cross-functional teams including Product, Engineering, and Customer Success. You will also coordinate with external stakeholders such as auditors, notified bodies, and suppliers.
REQUIREMENTS
1–3 years of experience in a QA/RA or Quality Management role in the medical device or health tech sector. Solid working knowledge of ISO 13485 and the EU Medical Device Regulation (MDR). Hands-on experience maintaining a QMS (document control, SOPs, CAPAs, supplier management, audit support). Strong organizational skills, attention to detail, and ability to manage multiple processes. Ability to write clear quality documentation and translate regulatory requirements into practical processes. Fluent in Spanish and English (written and spoken). Proactive, autonomous, and structured mindset.
Nice to have
- Experience with SaMD or software validation in regulated environments, and familiarity with FDA processes.
- Familiarity with post-market surveillance, technical documentation, or regulatory submissions.
- Exposure to QMS software platforms.
- Background in biomedical, industrial, or telecommunications engineering.
- Knowledge of ISO 27001 or other compliance frameworks.
WHAT WE OFFER
Fixed and variable salary; flexible benefits through Cobee (meal vouchers, transport, nursery). Remote work in an asynchronous environment, flexible working hours, team buildings (at least two per year). 23 days per year + your birthday + 6 local/regional holidays. Budget for training and personal development. Company laptop (Mac) and required equipment. The opportunity to join a team where you can create real impact on people’s lives.
How to apply
Apply online: https://tucuvipeople.factorialhr.com/apply/qara-specialist-289870
Contact
Sofia Nikolaeva, People & Culture Associate
Email: [email protected]