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Medical Regulatory and Compliance Officer
at Machine Medicine Technologies

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  • London
  • fulltime
  • ₤20000 - ₤50000 per year
  • -

About us

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.

About you

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.

Qualifications:

  • Minimum of a degree in regulation or related field

Experience:

  • 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

Skills:

  • 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

Job reference no. RCO920


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