Overview

The opportunity

Skin Analytics already has a well established clinical risk management system and clinical safety cases for all of our software products that comply with both ISO 14971 and DCB 0129. Our clinical risk activities are evidence based and constantly improving and growing as our products and deployments evolve

Reporting to, and working closely with, the Clinical Safety Director, you will undertake a range of risk management activities for new features being developed in our client platform (a non-medical device) and may also support risk management activities for our Software as a Medical Device (SaMD) products and other related new digital health products as they are scoped.

The primary focus of this role is for Clinical Safety but aspects of the role will also involve related activities such as supporting or being responsible for our accompanying documentation from a clinical / safety perspective. These include our respective user manuals and training material.

Responsibilities

  • Work collaboratively with our Product, Medical and Software Engineering team.
  • Undertake any required clinical risk management activities as determined by the Clinical Safety Director, according to DCB 0129, ISO 14971 and the company-wide clinical safety methodology and processes for new features and products. These activities may include:
  • Create or Update the Clinical Risk Management Plan for the Health IT System development and modification.
  • Undertake clinical risk management activities in accordance with the Clinical Risk Management Plan.
  • Maintain, update or create safety documentation including Hazard Logs and Clinical Safety Case Reports.
  • Undertake Clinical Hazard Identification exercises and gather and review evidence in the Clinical Risk Management File to ensure it is complete and supports the Clinical Safety Case Report
  • Update DCB 0129 documentation (Hazard Logs, Clinical Safety Case Reports or addendums) for client platform releases for our NHS organisations.
  • Undertake clinical risk assessments of issues identified post deployment as part of our weekly Complaints, Incidents and CAPA Review Board meeting.
  • Liaise with Partnerships and Product teams on supporting review and input of customer facing documents and training to ensure information for safety is appropriately covered.
  • As we are a fast growing organisation, other tasks might come up and offer you an opportunity to broaden your horizon, we look for someone who welcomes this.

Skills and Experience

  • Suitable Clinical qualification and experience
  • Experienced in risk management and its application to clinical domains as applied to Health IT Systems, particularly NHS Digital’s Clinical Safety Standard DCB 0129 and/or DCB 0160.
  • Ideally Knowledgeable in ISO 14971: Application of Risk Management in Medical Devices
  • Logical / analytical reasoning skills
  • Problem solving skills
  • Attention to detail
  • Ability to facilitate consensus – collaborative personality
  • Hold a current registration with an appropriate professional body relevant to their training and experience (GMC, NMC etc)
  • Have completed appropriate training e.g. NHS Digital’s Clinical Safety Training.

Why Skin Analytics

  • We are growing, and anticipate that our employees are going to have excellent opportunities for career progression
  • Competitive salaries
  • Flexible work, hybrid and remote options
  • Share options – if we succeed, you succeed
  • Open and transparent communication from the CEO down to everyone and back up.
  • Company funded private health insurance to our team
  • £500 budget for job related training
  • 33 days of annual leave per year (25 days annual leave + 8 bank holidays)
  • Enhanced parental leave (includes adoption & foster.

Diversity & Inclusion

We encourage people from all walks of life to apply and strive to eliminate unconscious bias in our recruitment process. We do not discriminate on ethnicity, religion, sexual orientation, gender identity, veteran or parental status or disability. We encourage candidates from underrepresented groups to apply. Skin Analytics runs a Diversity & Inclusion program with ambassadors working closely with all employees.

Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our employees agree complete their assigned training and to diligently follow all company quality management and information security processes.

About Skin Analytics

About Skin Analytics

Skin Analytics is a multiple award winning digital health company that has launched the world’s first AI supported Skin Cancer pathway. We want to build a future where no one dies from skin cancer. Every time our software is implemented, lives are saved. To achieve this, we work closely with hospital trusts, GP practices and health insurers Vitality and Bupa. Our platforms help patients access services quicker, and save clinicians time in diagnosing and treating skin cancer. Our AI can cut these hospital waiting lists up to 40%.

Our evidence based AI has been through rigorous clinical trials, and is regulated as a medical device. We have published our results in leading medical journals such as JAMA and we are in the process of conducting studies with large hospital groups in the US to secure FDA approval.

We don’t just talk about AI in healthcare, we implemented AI in healthcare and now save lives through early diagnosis. We are investing in our Clinical function to manage our ongoing and future studies. We are looking for a reliable, organised Data Manager who is also good at statistics to help us become a world leading company in AI diagnostics.