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    • Strong SaMD expertise, including standalone software or embedded medical software.
    • Existing auditor experience on behalf of a Notified Body.
    • Update and manage the contract element of the medical equipment asset register.
    • Experience of medical equipment management is desirable.
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    • Access to professional development in medical device regulation and compliance standards.
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    • Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
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    • Maintaining compliance with ISO 13485, IEC 62304 and relevant medical device regulations.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device…
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    • Scope to develop deeper expertise in medical device regulation and compliance frameworks.
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    • Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
    • Managing service contract renewals and maintaining accurate contract records.
    • Proactively manage the service/maintenance contract renewals prior to contract…
Contract Auditor (SaMD)
Computer Futures
·
3.8
London
Zero hours contract
Apply on company site

Job details

Pay information not provided
Zero hours contract
London

Full job description

We're supporting a growing medical device consulting organisation in the search for an experienced Lead Auditor. Key Requirements
  • Existing auditor experience on behalf of a Notified Body
  • Proven experience auditing against ISO 13485 and MDR.
  • Strong SaMD expertise, including standalone software or embedded medical software
  • QMS auditing expertise
Ideal Background
  • Experience working with MedTech start-ups and scale-ups
  • Comfortable conducting remote audits, document reviews, and technical evaluations
Package
  • Contract / zero-hours arrangement.
  • High volume of audit work available.
  • Rate up to €120 per hour.
  • Immediate requirement.
Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement. To find out more about Computer Futures please visit www.computerfutures.com Computer Futures, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales
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