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    • Strong SaMD expertise, including standalone software or embedded medical software.
    • Existing auditor experience on behalf of a Notified Body.
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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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    • Demonstrated experience in medical device regulatory affairs or compliance (medical device or pharmaceutical background).
    • What roles of this type could offer.
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    • Key contact for clients; Liaison between Clients, CRO, and Labcorp.
    • Displays leadership to ensure successful interactions between LabCorp study team members…
    • Shape medical strategy through external insights, scientific exchange and landscape mapping.
    • Take ownership of medical materials, scientific communications and…
    • GLP vendor oversight is often invisible when it's done well — and very visible when it isn't.
    • Own quality oversight of external partners supporting nonclinical…
    • The RCI & CAPA Senior Manager will lead Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) activities across research and development…
    • You will need to develop strong relationships with a diverse group of Stakeholders in the NHS and private medical sector; including surgeons, theatre managers…
    • Contribute to study communications, publications and medical congresses.
    • Pay:* £231–£250 per day PAYE basic or £305.93–£331.10 per day Umbrella.
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    • Coordinate contract review and approvals before acceptance.
    • You will open doors to new customers, uncover applications and build relationships that turn…
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    • Experience supporting Class III medical device development or comparable regulated environments.
    • Supporting the development and maintenance of regulatory…
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    • Domain: Class III medical device · regulatory affairs.
    • Supporting the development and maintenance of regulatory strategies for Class III medical device…
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    • Experience with Class III medical device regulatory affairs or equivalent compliance environment.
    • This is an opportunity to register your interest in future…
    • Prior experience supporting medical device submissions or regulatory inspections.
    • We are looking to build our regulatory affairs capabilities through a contract…
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    • Managing regulatory documentation and technical files for medical device submissions.
    • Scope to develop deeper expertise in medical device regulatory frameworks…

Job Post Details

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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