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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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    • Previous record of managing and directing a salesforce in the medical device industry.
    • Proven background in selling medical capital equipment.
    • ION® Endoluminal Territory Associate reports to the ION® Endoluminal Program Manager (EPM).
    • This individual will be primarily focused on supporting early…
    • Co-ordinate, lead and develop the team of internationally based regulatory consultants engaged in global notification services (ca. 10 - 15 staff).
    • Domain: Class III medical device · regulatory affairs.
    • Supporting the development and maintenance of regulatory strategies for Class III medical device…
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    • Prior industry experience in medical devices is strongly preferred.
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    • Private Medical Insurance package with additional medical cash plan scheme.
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    • In conjunction with the Director and other colleagues you will help achieve the overall business plan to grow and develop strategic healthcare planning as a…
    • Understanding of applicable regulatory requirements and industry guidance (esp. FDA, EMA, ICH, ISPE).
    • Drive standardization and governance by establishing…
    • Basic medical/therapeutic area and medical terminology knowledge.
    • Basic knowledge of all applicable regional / national country regulatory guidelines and EC…
    • Strong understanding of medical terminology, statistical concepts, and relevant scientific and regulatory guidelines.
    • Ability to interpret operational and regulatory requirements and translate them into practical program plans.
    • Understanding of cross-functional responsibilities…
    • Regulatory Engagement: Lead interactions with regulatory bodies (FDA, EMA) regarding newly developed COAs designed to replace older declining in relevance COAs.
    • Provides strategic regulatory advice towards efficient clinical development and navigation of US & European regulatory frameworks.

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Contract Auditor (SaMD)
Computer Futures
·
3.8
London
Zero hours contract
Apply on company site

Job details

Here’s how the job details align with your profile.

Job type

Zero hours contract

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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