Explore a career at Machine Medicine
Machine Medicine Technologies (MMT) uses computer vision and computational statistics to enhance the neurological assessment of patients. Their first product, KELVIN-PD, allows motor assessments in Parkinson’s disease to be performed, recorded and used both faster and better than has ever previously been possible. KELVIN-PD is already in use at multiple clinical sites and already possesses a CE mark, being a class I medical device. MMT aims to build the platform into a generalised tool for patient selection, surgical planning and device programming for machine brain interfacing, a revolutionary therapeutic innovation. This will require the product to be built to the standards of a class III medical device.
Medical Regulatory and Compliance Officer
You are an ambitious and intelligent professional with at least 3 years of experience in regulatory and compliance management in a medical industry, such as pharma or medical device development. You enjoy learning new things, are solution-focused and happy at the interface of technical, legal, and regulatory development. Impact matters to you.
List of main duties and responsibilities:
- Understand the company’s overall strategy and business operation.
- Maintain and organise the company’s Quality Management System (QMS).
- Remain up to date on industry rules, internal processes and business goals.
- Provide induction training to new starters and existing staff on the compliance requirements.
- Minimum of a degree in regulation or related field
- Minimum of 3 years’ experience in a medical device industry
- Experience operating a Quality Management System (ISO 13485)
Good to have:
- Experience with Medical Device Software (ISO 62304)
- Experience with Information Security (ISO 27001)
- Existing knowledge of regulatory and/or legal environment for UK medical device industry
- Strong written and verbal communication skills
- Proven Experience in data reporting and working accurately with sensitive data.
- Knowledge of the European Medical Device Directive and the new Medical Device Regulation