RA/QA Lead

The Senior RAQA Lead is a senior individual contributor and operational lead within the Regulatory Affairs and Quality Assurance function. Reporting to the Head of Regulatory and Compliance, the role owns day‑to‑day quality assurance across the software development lifecycle and provides regulatory expertise to support active EU MDR conformity assessment, post‑market obligations, and cross‑functional product quality processes. This role is suited to a quality and regulatory professional with deep knowledge of SaMD and software lifecycle who can operate independently, manage complex workstreams, and embed quality practices directly within engineering and product development processes.

Software Quality Assurance

• Own and maintain quality processes across the software development lifecycle in accordance with IEC 62304, including software classification, unit decomposition, and verification and validation activities.
• Embed quality gates within engineering workflows, ensuring change control, software release, and defect management processes meet regulatory requirements.
• Lead software problem resolution and non‑conformance processes, including root cause analysis and CAPA management.
• Define and maintain software quality metrics, traceability matrices, and test documentation to support Technical Documentation and audit readiness.
• Collaborate with engineering leads to maintain the software development and maintenance plan and ensure IEC 62304 artefacts are complete and current.

Quality Management System

• Own and maintain the QMS, ensuring continued compliance with ISO 13485 and EU MDR requirements.
• Lead the internal audit programme with a focus on software and product quality processes.
• Prepare for and support external audits, including Notified Body surveillance audits.
• Maintain document control processes and ensure version integrity across the quality system.

Regulatory Affairs

• Support maintenance and continuous improvement of the EU MDR Technical Documentation, including software documentation, intended purpose, risk management, and clinical evaluation.
• Monitor and assess regulatory intelligence across EU MDR and applicable international frameworks, communicating impact to the Head of Regulatory and Compliance.
• Coordinate with Notified Body contacts and the EU Authorized Representative on conformity assessment activities.
• Support post‑market surveillance and vigilance activities, including PMCF planning and PSUR preparation.

Risk Management

• Maintain the risk management file in accordance with ISO 14971, with particular focus on software‑related hazards and use error scenarios.
• Conduct and document risk assessments for product changes, software updates, new features, and new indications.
• Integrate risk outputs with clinical evaluation, software lifecycle documentation, and post‑market processes.

Cross‑functional Collaboration

• Act as the primary RAQA contact for product and engineering teams, providing regulatory and quality input at design review, sprint, and release stages.
• Support clinical evidence activities, including real‑world evidence study design and CER/CEP documentation.
• Contribute regulatory perspective to AI and algorithm governance, including EU AI Act obligations where applicable.

Team and Operations

• Provide operational oversight of RAQA workstreams and contribute to team planning and prioritisation.
• Mentor and support junior RAQA team members where applicable.
• Drive RAQA process improvement, tooling, and automation initiatives.

What We’re Looking For

Essential

• Significant experience in quality assurance or regulatory affairs within the medical device or digital health industry (minimum 5 years).
• Demonstrable expertise in IEC 62304 software lifecycle processes for medical device software.
• Strong working knowledge of EU MDR (2017/745) and ISO 13485.
• Experience with SaMD products, ideally in a cloud‑hosted or platform context.
• Proven ability to work directly with engineering and product teams to embed quality practices.
• Familiarity with Technical Documentation requirements, including software documentation, clinical evaluation, and risk management files.
• Excellent written communication skills, with the ability to produce precise regulatory and quality documentation.

Desirable

• Knowledge of ISO 14971 and usability engineering (IEC 62366).
• Exposure to post‑market surveillance, vigilance, and PMCF activities.
• Familiarity with EU AI Act obligations relevant to software as a medical device.
• Experience working with Notified Bodies or Authorized Representatives.
• Background in virtual care, remote monitoring, or digital therapeutics.
• Experience with cybersecurity standards relevant to connected medical devices (e.g., IEC 81001‑5‑1).

Benefits

• 25 days annual leave plus up to 8 UK bank holidays, option to buy or sell holidays.
• Flexible remote options and remote working stipend.
• 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, phased return to paid work, sick pay.
• Free daily lunch, pet‑friendly office.
• £500 L&D budget per person, cycle to work scheme.
• 24/7 GP appointments, mental health support, nutrition and fitness advice, second opinions and health checks.

In Return for Your Hard Work

• A competitive compensation package (base plus stock options), with half‑year and annual performance reviews.
• The chance to work on patient‑first, system‑level healthcare challenges in one of Europe’s leading healthtech companies.
• Opportunities for growth and leadership with full support to challenge the status quo, own your impact, and continue developing.

Diversity at Doccla

We embrace diversity. To build a great product, we need a team with a wide range of perspectives, backgrounds, and experiences. We’re committed to equal opportunity hiring regardless of race, religion, gender identity, sexual orientation, age, disability or background. If you're excited about the role, we encourage you to apply even if your experience doesn't match every point.

Safer Recruitment

We are committed to safer recruitment practices. As Doccla is a CQC registered company, a Disclosure and Barring Service (DBS) check will be required for all roles. It is an offence to apply for such work if you are barred from working with children or vulnerable adults.