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 s...