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Quality Management as a Service

About 8foldGovernance.

8foldGovernance is a specialist healthcare compliance, professional services business for global healthcare innovators.

As we grow, we stay focused on our mission to ensure transformative technologies make a real impact. By expanding our expert team, we’re ready to meet the growing demand for our people-first, practical solutions – helping innovators and leaders navigate complex challenges and deliver better care and outcomes.

Why work with 8fold?

  • As a value-driven business, we focus on doing the right thing for our people and clients, creating a culture where everyone is valued and empowered.
  • We’re fully remote, giving you the flexibility to work from wherever suits you, as long as there’s reliable WiFi and space for necessary equipment. We also believe in the importance of connection, so occasional travel for team meetings or events is required (expenses covered) to strengthen collaboration.
  • You’ll have the opportunity to work with a team of subject matter experts and consultants who are well-regarded in the industry. We share knowledge openly, recognising that understanding and continuous learning are key to our success.
  • We offer private healthcare insurance, with additional discounts and offers, because we believe in supporting your wellbeing as part of a balanced livelihood.
  • As a close-knit team, we value balance and creating time for what we enjoy – whether that’s our charitable work, or travelling together.

Job Openings.

Clinical Safety Officer - Entry Level

Join us as a Clinical Safety Officer.

We are seeking healthcare professionals with an interest in technology and patient safety. We welcome applications from Nurses, Paramedics, Midwives, Mental Health Nurses, Pharmacists, Radiographers, and all UK-registered AHPs.

Who You Are:

  • A registered healthcare professional with at least 3 years of experience in your field
  • Enthusiastic about health technology, innovation, and advancements in AI, with professional experience or interest in this area
  • Aware of clinical safety and medical device standards such as DCB0129, DCB0160, ISO 14971, and ISO 13485
  • Motivated to build expertise in clinical risk management while expanding your knowledge of medical device regulations and the broader quality and regulatory landscape
  • Analytical and detail-oriented, with the ability to critically assess risks and design effective mitigation strategies
  • Highly organised, and capable of managing multiple complex projects and tasks while meeting deadlines
  • An excellent communicator, adept at presenting complex information clearly and building relationships with diverse stakeholders
  • A practical and resourceful problem solver, determined to address challenges and deliver effective solutions
  • Collaborative and team-oriented, thriving in environments where you can work with colleagues and clients to achieve shared goals
  • You are efficient and pragmatic, with a strong ability to prioritise tasks effectively, ensuring that time and resources are utilised to deliver high-quality results

What the Job Involves:

  • Applying clinical risk management frameworks, including DCB0129, DCB0160, and ISO 14971, to ensure compliance and patient safety
  • Developing Clinical Safety Cases, including evidence based arguments to demonstrate product safety.
  • Creating and maintaining Hazard Logs to track identified risks, mitigations, and ongoing monitoring.
  • Creating and maintaining Risk Management Plans and Clinical Safety Case Reports aligned with DCB0129, DCB0160, and ISO 14971 standards.
  • Identifying potential risks and designing technical and process-oriented mitigation strategies throughout the product lifecycle
  • Conducting risk analysis of health technologies to ensure robust testing and development practices are implemented and documented
  • Collaborating with external partners, including health technology developers and medical device manufacturers, to support safe product development.
  • Working closely with internal teams, including medical device and information governance/security colleagues
  • Staying up to date with industry trends, regulatory updates, and advancements in health technology and AI

Why work with us?

  • We are a values-driven business and we pride ourselves in building a healthy culture where all employees are valued.
  • We offer flexible, remote working (from a suitable working environment with sufficient space for equipment – e.g. screen, keyboard, mouse – and an adequate internet connection for video calls)
  • We provide private healthcare insurance.
  • You will have the opportunity to work with specialists and consultants who are top of their game within the industry.
  • For the right candidate, we would be able to support professional certification, e.g. CQI, IRCA, RAPS/RAC.

Future Development Opportunities:

  • Comprehensive training and development in a range of regulatory standards
  • Opportunities to take the lead on projects and develop new products where you identify potential
  • Collaborating with internal experts across various teams to gain deeper insights and knowledge
  • Developing skills in areas such as:
      • Software development plans
      • Usability engineering
      • Clinical evaluation
      • Post-market surveillance

Compensation and Benefits

  • We are a values-driven business and we pride ourselves in building a healthy culture where all employees are valued.  
  • We offer flexible working, our team is fully remote.
  • Salary is negotiable and will reflect the successful candidate’s expertise and background.
  • We provide private healthcare insurance.
  • You will have the opportunity to work with specialists and consultants who are top of their game within the industry.

Hiring Process

  • First Interviews:  Video conferencing meeting
  • Second Interview:  Face-to-face

Check out our website for more information about the company and apply for the role

Apply Now

Clinical Safety Officers

We’re looking for top-flight clinicians with an active interest in digital health technology to act as Clinical Safety Officers.

You’ll have the opportunity to work with innovative and dynamic health technology companies, assisting them in calculating clinical safety thinking into their software development practices.

You will be supported and mentored by a team with extensive experience in clinical risk management across digital health technology. We believe our service is unique as we apply advanced technology product management and information governance experience to the role of our Clinical Safety Officers (CSO).  To learn more about our approach, check out our blog: What a good Clinical Safety Officer (CSO) brings to digital health tech solutions.

Responsibilities

  • Working closely with customer teams to support them on their journey to clinical safety and DCB0129 compliance.

  • Implementation of risk management systems into digital health manufacturer organisations.

  • Conducting risk analysis of digital health IT systems and Software as a Medical Device systems, in collaboration with multidisciplinary teams.

  • Communication of risk management process outputs to NHS customer organisations.

  • Writing Clinical Safety Case Reports and Risk Management Reports.

  • Methodical documentation of digital health IT risks into Hazard Logs.

  • Supporting digital health manufacturers in risk management on an ongoing basis through the lifecycle of the digital health product(s).
  • Clinical incident management and reporting.

Experience

We welcome the opportunity to hear from doctors, nurses, pharmacists and physiotherapists. However, to apply for

  • Have an active registration with a UK professional body.

  • Have an understanding of safety and risk management in health IT (hazard logs and safety cases).

  • Have several years of experience of working in the digital health sector – this can be for a digital technology supplier or for the NHS.

  • Be self-starter with excellent analytical skills.

  • Be adept at producing clear and concise safety documentation.

  • Have completed the DCB0129 training course (we cannot interview applicants that do not have this training).

You must be familiar with the requirements of the DCB0129 and DCB0160 standards. Ideally, you will have been involved in setting up and/or participating in clinical risk management functions compliant with this guidance. Previous experience as a Clinical Safety Officer is especially advantageous. However, what matters most to us is a passion for digital health and a willingness to improve the health system to deliver better and safer patient care and experience.

Please express interest by emailing your CV to: info@8foldgovernance.com.

Information Governance/Data Protection Professional

We’re looking for enthusiastic, self-motivated and well organised Information Governance and Data Protection Professionals. Our Information Governance offerings are growing fast and we are looking for some to bring up-to-speed to support existing and new clients.

This role is fully remote working and we are fully supportive of flexible working arrangements (including part-time working). We meet face-to-face for team events at least quarterly (expenses covered).

We ask that you have a suitable, private working environment to accommodate a second display screen and a strong WiFi connection for video calls

Main Duties and Responsibilities

  • Creating and implementing Information Governance Policies for clients.

  • Performing gap analyses and audits of client policies and records.

  • Performing Data Protection Impact Assessments (DPIA) for clients and their products.

  • Advising clients on Information Governance

  • Acting as Data Protection Officer for clients

  • Investigating and reporting data breaches.
  • Coordinating with other teams across the business to translate client requirements into clear business objectives, including active participation in client meetings.

About You

You are a fresh-thinking, collaborative individual coupled with confidence, energy and self-awareness. You enjoy and thrive working as part of a diverse group of individuals and work well independently as well as part of the wider team.

You have experience with UK or EU Data Protection Law, preferably in a health-related environment.

You might have experience with NHS Data Security and Protection Toolkit (DSPT), Digital Technology Assessment Criteria (DTAC), ISO 27001, Information Security and/or Cyber Security or acting as a Data Protection Officer.

Please express interest by emailing your CV to: info@8foldgovernance.com.