QARA Specialist

Cure Talent are delighted to be partnered with an innovative digital health company developing cutting-edge software-based medical technologies. As they prepare for upcoming FDA and EU MDR submissions, we have an exciting opportunity for a QA & Regulatory Affairs Specialist to join their growing team.

As the new QA & RA Specialist, you will take ownership of day-to-day quality and regulatory activities, supporting the development and maintenance of a Quality Management System for Software as a Medical Device (SaMD). Working closely with an experienced Regulatory Affairs Consultant, you will play a key role in documentation, audits, and submission preparation, gaining invaluable exposure across international regulatory frameworks.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) for SaMD in line with ISO 13485 and IEC 62304.
• Ensure compliance with ISO 14971, GDPR, HIPAA, and related privacy frameworks.
• Prepare and maintain key documentation including DHF, risk files, validation reports, and traceability matrices.
• Support FDA and EU MDR submissions, as well as internal audits and external inspections.
• Manage CAPA, post-market surveillance, and audit readiness.
• Collaborate cross-functionally with engineering and product teams to embed quality and compliance throughout development.
• Champion a culture of quality and continuous improvement across the organisation.

Experience and Skills Required

• Proven experience in QA and/or Regulatory Affairs within medical devices, ideally SaMD.
• Strong understanding of ISO 13485, IEC 62304, and ISO 14971.
• Experience working in fast-paced or startup environments.
• Excellent technical documentation, organisation, and communication skills.
• Proactive and adaptable, with strong problem-solving ability and attention to detail.
• Exposure to FDA 510(k), EU MDR Class II submissions, or audit participation advantageous.
• Familiarity with software validation or cybersecurity documentation desirable.

If you’re a motivated QA & RA professional looking to deepen your regulatory expertise in a fast-paced digital health environment, we’d love to hear from you.