Quality and Risk Management Specialist

12 hours ago


Basingstoke, Hampshire, United Kingdom Vision RT Ltd Full time

Vision RT Ltd, a leading MedTech company at the forefront of transforming radiation therapy, is seeking a highly skilled Quality and Risk Management Specialist to join its team.

Job Description

This is a 3-month rolling contract role that sits within the compliance team and involves creating and maintaining Risk Management files for Vision RT medical devices. The ideal candidate will have a minimum of 3 years' commercial experience in risk management for medical devices or a related field.

Responsibilities
  • Assist in the creation and maintenance of Risk Management files for Vision RT medical devices, including Failure mode effects analysis scoring systems, Risk management plans, Preliminary hazard analysis reports, Risk hazard analysis reports, Register of risks (DFMEA), Risk-benefit analysis, Risk-traceability analysis, Anomalies review reports, and Risk management reports.
  • Participate in risk reviews for proposed design changes.
  • Create risk control requirements as inputs to product design.
  • Conduct risk reviews of post-market surveillance data.
Required Skills and Qualifications

The successful candidate will possess excellent verbal communication, writing, and presentation skills, as well as a working knowledge of application lifecycle management tools used in medical device development. Fluency in written and spoken English is essential, and experience of risk management of active medical devices containing software is desirable.

Salary and Benefits

We offer a competitive salary of £60,000 - £80,000 per annum, depending on experience, plus benefits including occasional UK and international travel opportunities.



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