About Doccla
Doccla is redefining where and how healthcare is delivered. Our Virtual Ward and Remote Monitoring solutions enable hospitals and health systems to care for patients at home, covering early discharge, acute recovery, long‑term condition management, and proactive care. We provide clinicians with medical‑grade devices, logistics, patient onboarding, EHR integration, and an end‑to‑end clinical platform built around real‑world workflows. We operate across the UK, Ireland, France, and the DACH region, supporting hospitals and health systems to reduce pressure, improve outcomes, and create resilient care models.
Role Summary
The RAQA Specialist will support software quality, validation, and notified body remediation activities. This position is critical to maintain delivery continuity during active Technical Documentation review cycles and ongoing remediation of non‑conformities (NCs). Without this backfill, regulatory and validation activities would be delayed, increasing certification and compliance risk.
Responsibilities
Technical and Product Nonconformity Management
- Own follow‑up and closure of technical and product‑related nonconformities raised by the notified body.
- Draft and maintain NC responses and objective evidence relating to software lifecycle, validation, and risk management documentation.
- Coordinate with engineering and RAQA to ensure corrective actions are implemented and review‑cycle ready.
- Support CAPA activities and internal audit follow‑ups where software or product‑quality root causes are identified.
Software Validation Planning and Oversight
- Own preparation, maintenance, and update of software validation plans in line with IEC 62304, ISO 13485, and internal QMS requirements.
- Ensure validation scope aligns with intended use, risk classification, and release strategy.
- Review validation protocols and reports to ensure completeness, traceability, and regulatory defensibility.
Software Lifecycle and Risk Management Compliance
- Review software requirements, traceability matrices, and lifecycle documentation in accordance with IEC 62304.
- Support maintenance of the risk management file in line with ISO 14971, ensuring linkage to validation and Technical Documentation.
Qualifications
3–6 years’ experience in Medical Device / SaMD QA or RAQA Engineering. Proven track record in managing non‑conformities and performing software validation.
Must‑Have Standards & Technical Experience
- ISO 14971: Expert knowledge in risk management application.
- IEC 62304: Comprehensive understanding of software lifecycle processes.
- EU MDR Technical Documentation: Proven experience in preparing and maintaining documentation for regulatory compliance.
Work Environment & Culture
We empower everyone to take ownership of their work and the company’s mission. Ethics, patient safety, and outcomes are core values. Expectations include a can‑do attitude, action‑oriented approach, and willingness to learn and grow through open feedback. The team is hybrid, with offices in London, Denmark, Germany, and Stockholm; most team members are London‑based with flexible remote options.
Benefits
- 25 days annual leave plus up to 8 UK bank holidays (option to buy or sell holidays).
- Flexible remote working options.
- Employee stock options.
- 4% pension on full basic pay.
- 4x salary life insurance.
- Private health insurance.
- 4 months full pay for birthing parent; 4 weeks full pay for non‑birthing parent.
- Sick pay.
- Free daily lunch at London HQ.
- Pet‑friendly office.
- £500 learning & development budget per person.
- Cycle‑to‑work scheme.
- 24/7 GP appointments through Smart Health.
- Mental health support.
- Nutrition and fitness advice.
- Second opinions & health checks.
- Competitive compensation package with half‑year and annual performance reviews.
- Opportunities for growth and leadership with full support.
Diversity & Inclusion
We accept candidates regardless of race, religion, gender identity, sexual orientation, age, disability, or background. Equality and diversity are central to our hiring and workplace.
Safer Recruitment
All roles require a Disclosure and Barring Service (DBS) check as a condition of employment.
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