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

Were 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 youll 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. Youll 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 worlds 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 K2s 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 K2s 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 ().