Description:
This isn’t just about ticking boxes. You’ll be instrumental in embedding robust governance and compliance frameworks—supporting high standards of care while enabling safe innovation. You’ll help bring scalable, digitally‑enabled health services to market that improve real patient outcomes.
Key Responsibilities
- Governance Strategy
- Design, implement, and own the governance strategy—promoting continuous improvement and a culture of safe innovation.
- Quality Management Systems (QMS)
- Lead the full lifecycle of QMS—including audit cycles, risk registers, clinical governance—and act as super‑user of the eQMS.
- Information & Data Governance
- Collaborate with technical teams and the Data Protection Officer to manage GDPR and information governance compliance.
- Performance & Incident Management
- Analyse performance data—from audits to safety incidents—and manage incident reporting, investigations, and Duty of Candour processes.
- Leadership & Oversight
- Provide expert advice on governance to the Executive Team and Board; prepare the organisation for CQC inspections and MDR readiness.
- Audit & Quality Improvement
- Lead corporate and clinical audit programmes, ensure action plans are delivered, and embed continuous improvement.
- Policy Development
- Write and maintain governance policies, SOPs, training protocols, and induction materials.
- Clinical & Product Collaboration
- Work closely with clinical, operational, and product teams to monitor and improve outcomes and safeguard patient experience.
- Regulatory & Accreditation Compliance
- Take the lead on Medical Device Regulation processes and spearhead other accreditations (e.g., ISO 27001) with specialist support.
Your Profile
Essential:
- 5+ years in senior roles focused on governance, quality, or regulation—ideally in health or health tech
- Proven track record with QMS, audits, and risk frameworks
- Deep knowledge of CQC standards, GDPR, and MDR
- Experience designing governance frameworks in fast-paced, growing organisations
- Excellent communication, influencing, and stakeholder management skills
- Data-driven at heart, with strong quality improvement and analytical capability
- Skilled in policy writing, audit methodologies, and root-cause analysis
- Strong project-management skills and organised approach
- UK work authorisation
Desirable:
- Experience in digital health / health technology
- Familiarity with ISO 13485 or ISO 27001
- Clinical or health policy background