Digital Midwife / Clinical Safety Officer

Are you passionate about advancing patient safety in digital healthcare and transforming maternity care? Are you ready to take your career to the next level and make a real difference in healthcare?

We’re looking for a dedicated and visionary Clinical Safety Officer (CSO) to join our innovative team, supporting our mission to deliver safe, effective, and patient-centered digital solutions for maternity.

As CSO, you’ll lead the clinical safety agenda across our digital platforms, ensuring compliance with regulatory standards and embedding safety by design into every stage of product development. You’ll work closely with clinical, technical, and operational teams to proactively identify risks, implement robust safety governance, and drive continuous improvement. Your leadership will be instrumental in shaping a culture of safety, trust, and excellence empowering clinicians and patients alike through technology that truly makes a difference.

Harris Health Alliance

Formed in 2024, Harris Health Alliance comprises four well-established and distinguished brands, all operating within the healthcare sector and delivering innovative software solutions to clients worldwide.

Harris Health Alliance is part of Harris Computer Group, a provider of mission-critical software solutions for the public sector, healthcare, utilities, and private sector verticals throughout the UK, Europe, North America, Asia, and Australia.

Harris’ strategy focuses on acquiring software businesses, strengthening and managing them well, and growing them for the future. Our companies provide mission-critical software solutions to a global customer base across various vertical markets. We are a part of Constellation Software Inc. (TSX: CSU), one of the world’s most active acquirers of software businesses.

At Harris, we strive to create a respectful and united environment where all members of our globally diverse community are empowered and have equitable opportunities to succeed.

Location

Fully remote working environment with occasional travel required to our collaborative offices in Chippenham, Swindon, Chester, and Plymouth or client sites as needed.

Responsibilities

Clinical Safety & Risk Management

• 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.

Regulatory & Medical Device Compliance

• 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.

Customer Engagement & Clinical Support

• 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.

Product Development & Innovation

• 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.

Governance, Training & Advocacy

• 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.

Cross-Brand Collaboration

• 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.

Experience

Essential:

• 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).

Desirable:

• 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.

Skills

• 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.

Additional Info

• 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).