Digital Midwife / Clinical Safety Officer

• Serve as the named Clinical Safety Officer (CSO) for K2’s maternity solutions in accordance with DCB0129 and DCB0160.
• Lead the development, review, and maintenance of Clinical Safety Cases and Hazard Logs.
• Conduct proactive clinical risk assessments during product development and updates.
• Monitor, investigate, and report clinical incidents and near misses, ensuring root cause analysis and corrective actions are implemented.
• Provide clinical input into post-market surveillance activities, including trend analysis, clinical evaluation reports including literature search, post market clinical follow-up studies, and vigilance reporting.

• Support compliance with UK MDR, EU MDR, and ISO standards (e.g., ISO 13485).
• Contribute to the preparation of regulatory submissions and audits by providing clinical evidence and safety documentation.
• Participate in internal and external audits, inspections, and reviews by regulatory bodies and notified bodies.
• Ensure clinical documentation aligns with the latest regulatory and clinical best practices.

• Act as a clinical subject matter expert during pre-sales discussions, product demonstrations, and tender responses.
• Support the Customer Success team in onboarding new clients, delivering clinical training, and ensuring safe and effective product use.
• Provide ongoing clinical support to customers, addressing queries, gathering feedback, and facilitating continuous improvement.
• Participate in user group meetings, workshops, and conferences to represent the clinical perspective and promote K2’s solutions.

• Collaborate with product managers, UX designers, and software developers to ensure clinical safety and usability are embedded in product design.
• Review and validate clinical content, workflows, and decision support logic within the software.
• Contribute to user acceptance testing (UAT) and clinical validation of new features and updates.
• Stay informed of emerging clinical practices, guidelines, and technologies in maternity care to inform product innovation.

• Develop and deliver internal training on clinical safety, risk management, and regulatory compliance.
• Promote a culture of clinical safety and continuous improvement across the organization.
• Represent K2 in external forums, working groups, and professional networks related to digital health and maternity care.
• Support the development of clinical policies, procedures, and best practice guidelines.

• Provide clinical oversight and input into projects involving Quicksilva & Genial, particularly where interoperability, data exchange, and integration with NHS systems impact clinical workflows and patient safety.
• Contribute to multi-brand initiatives that enhance the overall digital health ecosystem, leveraging synergies between maternity, genomics, and health IT infrastructure.
• Participate in cross-functional working groups and innovation projects that span multiple brands, ensuring a unified and clinically sound approach to product development and delivery.

• Registered healthcare professional (e.g., Midwife, Nurse, Doctor) with current registration (e.g., NMC, GMC).
• Minimum 5 years of clinical experience in maternity or obstetrics.
• Experience in clinical risk management and safety case development.
• Familiarity with medical device regulations and digital health standards (e.g., DCB0129/0160).

• Experience working in or with health tech companies.
• Knowledge of NHS Digital, NICE, and UK health system frameworks.
• Experience in customer-facing roles or training delivery.

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Detail-oriented with a commitment to clinical excellence.
• Ability to work independently and collaboratively in a fast-paced environment.
• Strong advocate for mentorship, learning culture, and diversity in tech.

• A passion for delivering innovative products that solve real customer problems.
• A curious, forward-thinking attitude with a collaborative and adaptable approach to problem-solving.

• Engaged to represent our business, our work ethic and embody Our Values (harriscomputer.com).

eQuest