Ada Health

Compliance

• Develop, maintain, and improve quality management systems, SOPs, and technical documentation to ensure compliance with ISO 13485, MDR, and other applicable regulations.
• Provide technical writing support and act as subject matter expert (SME) for quality and regulatory documentation, processes, and procedures.
• Manage risk across medical device lifecycles, including risk assessments, failure mode analyses, mitigation strategies, and documentation to minimise potential harm.
• Review and assess nonconformance records, audit findings, and corrective/preventive actions to ensure timely resolution and regulatory compliance.
• Plan, prepare, and participate in internal and external audits and inspections, including supplier audits, ensuring readiness and adherence to quality and regulatory standards.
• Provide training and guidance to internal stakeholders on quality systems, regulatory compliance, risk management, and relevant standards.
• Support verification, validation, monitoring, and inspection activities for assigned product lines and processes, including production controls.
• Collaborate cross-functionally to assess, approve, and manage changes to products and processes in compliance with regulatory requirements.
• Drive continuous improvement initiatives in quality, risk management, and regulatory affairs to enhance efficiency, compliance, and patient safety.
• Serve as a proactive ambassador for quality and regulatory compliance across the organisation.

Quality, Regulatory & Risk Manager

QA Engineer

• Lead the development and implementation of regulatory and quality assurance strategies, ensuring compliance with MDR, FDA, and other international medical device regulations.
• Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team, setting clear priorities, working directly alongside stakeholders, and building a lean, high-performance culture that adapts as Ada’s regulatory and quality needs evolve.
• Act as an internal SME (Subject Matter Expert) on regulatory requirements, industry trends, and compliance best practices, as required.
• Proactively advise management on regulatory changes and implications for Ada.
• Embed and automate Compliance in the SDLC: Partner with Engineering and Product to integrate regulatory checkpoints into agile workflows and automate QMS processes to reduce friction and increase delivery velocity.
• Oversee internal and external audits, including Notified Body audits and regulatory inspections.
• Serve as the primary liaison with Competent Authorities and Notified Bodies representing the company in all regulatory discussions to ensure compliance and strategic alignment.
• Oversee regulatory submissions, including Technical Documentation reviews, with a focus on Europe, the UK and USA. Act as the company’s PRRC (Person Responsible for Regulatory Compliance) under EU MDR (Article 15).
• Lead the global vigilance strategy, ensuring the identification, investigation and reporting of serious incidents and field safety corrective actions to the appropriate regulatory bodies (e.g., BfArM, FDA, MHRA).
• Act as the Management Representative under ISO 13485, reporting to senior management on quality and regulatory compliance performance, including Management Reviews.
• Ensure the technical documentation and the EU declaration of conformity for medical devices are drawn up and kept up-to-date.

Head of Quality Assurance – Regulatory Affairs

• Extend and enhance our existing, general-purpose E2E test automation framework (Kotlin and JavaScript-based) to ensure robust coverage for our new conversational AI product.
• Develop new, service-level test automation using Python to support your team's deployment pipeline and product stack.
• Develop and execute novel testing strategies specifically for conversational AI and LLM-based features, focusing on performance, accuracy, and user interaction quality.
• Champion a 'whole-team' approach to quality, coaching and mentoring engineers, designers, and product managers in testing and risk-based analysis.
• Continuously test throughout the entire SDLC, from idea and design to code and production, using a smart mix of exploratory and automated testing techniques.
• Collaborate with engineers to identify and mitigate integration risks at the API and system level, thinking deeply about how our services interact.
• Document and report testing outcomes clearly, ensuring all documentation and approaches meet regulatory and compliance standards while proactively improving compliance procedures.
• Drive the internal quality community, actively share your knowledge, and help raise the bar for testing and quality across the entire engineering team.

Quality, Regulatory & Risk Manager

Head of Quality Assurance – Regulatory Affairs

Senior Quality Engineer