QARA Manager

Barcelona - Spain

Monthly Salary: Not Disclosed

Posted on: 21 hours ago

Vacancies: 1 Vacancy

Job Summary

QARA Manager

Are you passionate about technology regulatory strategy and making a real impact in global healthcare At QMENTA we are transforming neuroimaging with AI and cloud-based solutions. Were looking for a QARA Manager to lead our regulatory strategy and ensure compliance across our advanced healthcare imaging and data management platforms.

Who we are

QMENTA is a cutting-edge software company providing a comprehensive platform for managing analyzing and interpreting medical images in research and clinical trials. Our technology enables faster diagnosis of neurological diseases like Parkinsons Alzheimers and multiple sclerosis and accelerates clinical trials through powerful AI-driven tools.

Our scalable cloud-based infrastructure integrates AI-powered imaging biomarkers and automated workflows to enhance medical imaging accuracy and collaboration across global research teams. If youre excited to drive innovation in healthcare and work with mission-driven colleagues QMENTA is the place for you!

What Youll Do

Own and continuously improve QMENTAs Quality Management System (QMS) ensuring full compliance with applicable standards and regulations for a software-as-a-service neuroimaging platform.

Lead the Documentation Control and Documentation Change Control processes maintaining accuracy and traceability across all QMS artifacts.

Design coordinate and lead internal and external QMS audits; prepare all required documentation and manage responses to findings.

Define measure and report on quality KPIs to senior leadership including preparation and facilitation of Management Review Meetings.

Drive the full lifecycle of Corrective and Preventive Actions (CAPA) ensuring timely resolution of non-conformities.

Create maintain and implement Standard Operating Procedures (SOPs) policies and work instructions; lead adoption across teams.

Serve as the primary point of contact for GDPR and HIPAA compliance within the QMS generating and maintaining all required records and evidence.

Lead QMS onboarding for new employees and deliver ongoing internal training to ensure consistent implementation of quality processes.

Sign and approve QARA-related documents on behalf of the QARA function.

Stay current on evolving regulations and proactively assess their impact on QMENTAs compliance posture.

Maintain traceability of documentation from Engineering and Customer Success teams in line with our QMS and SDLC (Design Development and Maintenance).

Manage all HR-related records within the QMS in collaboration with the People & Legal team (onboarding training records job descriptions org chart).

Support vendor qualification processes including participation in Vendor Questionnaires from CROs and other partners.

Assist with premarket FDA CE and other international regulatory submissions as needed.

Act as a liaison to external auditors regulatory bodies and enterprise customer security/compliance teams.

What Were Looking For

5 years of hands-on experience in Quality Assurance and/or Regulatory Affairs within software health tech or biotech environments.

Demonstrated ability to own and manage a QMS independently without day-to-day supervision.

Deep working knowledge of FDA 21 CFR Part 11 & 820 ISO 27001 SOC 2 GDPR HIPAA IEC 62304 and practical experience implementing or maintaining compliance under these frameworks.

Familiarity with ISO 13485 FDA 510(k) ISO 14971 and GxP principles is a strong plus.

Proven experience in software companies (SaaS healthtech or life sciences software); experience in clinical research or neuroimaging environments is a bonus.

Strong track record of designing and leading internal/external audits CAPA processes and Management Review cycles.

Exceptional written and verbal communication skills in English; Spanish is a plus.

Detail-oriented structured thinker who can manage multiple workstreams simultaneously with minimal oversight.

Proactive solutions-focused approach you identify gaps before they become problems.

Degree in Biomedical Engineering Engineering Life Sciences or a related field.

What We Offer

23 paid vacation days per year plus local public holidays.
Flexible compensation plan including meal vouchers and private health insurance.
Hybrid work model: 2 days per week at the office with flexible schedule.
Modern office in Barcelona well-connected by public transport.
Inclusive and diverse culture where your voice matters and you can make a difference.

Ready to make a real-world impact

If youre excited by the idea of leveraging regulatory expertise to drive innovation in healthcare apply now! Wed love to hear from you.

We Are an Equal Opportunity Employer

QMENTA is proud to be an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. We welcome applicants of any race color religion (or no religion) national origin gender gender identity sexual orientation age marital or civil status pregnancy disability or any other legally protected characteristic. At QMENTA we believe that a diverse team makes better decisions and drives innovation.

Required Experience:

Manager

QARA ManagerAre you passionate about technology regulatory strategy and making a real impact in global healthcare At QMENTA we are transforming neuroimaging with AI and cloud-based solutions. Were looking for a QARA Manager to lead our regulatory strategy and ensure compliance across our advanced he...