worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯
worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯
and external stakeholders. Good communication skills. Collaborative and willing to listen to others ideas. Technical knowledge (platform/backend) is advantageous 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 More ❯
MDR would be advantageous. Previous medical device experience is a bonus. Clear communication skills. Comfortable in dealing with triage clinical queries. 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 More ❯
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 ISO13485, 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 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 ISO13485, 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 (ISO13485) and/or Certified Quality Auditor (CQA) is a plus. Competitive salary Share options package - all our employees have ownership in the company Private healthcare 25 days annual leave (+ company shut down in More ❯
Manchester Area, United Kingdom Hybrid / WFH Options
Impax Recruitment
Engineering, Computer Vision, or related field (or MSc + significant experience) Solid grasp of image segmentation, 3D data handling, and deep learning architectures Bonus: experience in regulated environments (e.g. ISO13485, FDA) ✅ What’s On Offer High-impact work shaping the future of AI in healthcare Collaborate with exceptional talent in a mission-driven environment Flexible remote/ More ❯
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 standards (e.g., ISO13485). Contribute to the preparation of regulatory submissions and audits by providing clinical evidence and safety documentation. Participate in internal and external audits More ❯