ABOUT SKIN ANALYTICS

Skin Analytics is an award-winning, health tech company that has launched the world’s first AI-supported Skin Cancer pathway for a faster skin cancer diagnosis.
We are the first company to receive a NICE recommendation for an autonomous AI medical device to be used across the NHS dermatology pathways, which is deployed in more than 25 NHS organisations, and growing. Additionally, we collaborate with some of the largest health insurers to reach patients in their own homes. We recently raised a £15M series B funding round, and after receiving our Class III EU MDR certification, we are ready to scale internationally.
We are a team of passionate people who want to build a future where no one dies from skin cancer

REQUIREMENTS

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality Management, or related field.
• Minimum 5 years of hands-on QMS management experience in medical devices, preferably with AI/Software as a Medical Device (SaMD) products.
• Demonstrable expertise in ISO 13485, EU MDR and FDA QSR (21 CFR 820) quality system requirements.
• Proven track record supporting external audits (notified body, FDA inspections).
• Experience leading significant management system changes and improvements.
• Strong analytical and problem-solving skills, with ability to find pragmatic and creative solutions.
• Certification as a Lead Auditor (ISO 13485) and/or Certified Quality Auditor (CQA) is a plus.

THE ROLE

The Quality Systems Manager ensures the effectiveness of our quality and information security systems, supporting compliance with global medical device regulations. They lead audit preparation, certification efforts, and continuous system improvements. This role also supports the integration of AI-specific quality standards into our operations. You’ll be at the forefront of a cutting-edge AI product that’s revolutionising medical diagnostics and transforming patient care.

KEY RESPONSIBILITIES

• Oversee and develop our medical device Quality Management System (QMS) and Information Security Management System (ISMS), ensuring compliance with ISO 13485, MDSAP, US FDA QSR, EU MDR and ISO 27001.
• Implement and secure certification for an Artificial Intelligence Management System in line with ISO 42001 and/or equivalent CENELEC standard(s).
• Act as primary liaison for certification bodies and regulatory authorities during external audits and inspections.
• Oversee the drafting and updating of QMS, ISMS procedures, work instructions and forms; ensure effective document control and distribution.
• Oversee CAPA and complaint investigations for our medical devices and ensure that activities are initiated, planned, executed and closed within defined timelines.
• Analyse trends from quality management system data, coordinate internal audits, recommend systemic improvements, and report to management on QMS & ISMS effectiveness.
• Lead our quality training program and mentor cross-functional teams on quality best practices and compliance principles.