Skip to main content
Post your CV and find your next job on Indeed!

Regulatory Affairs Contract Medical Devices jobs

Sort by: -
    • Strong SaMD expertise, including standalone software or embedded medical software.
    • Existing auditor experience on behalf of a Notified Body.
    • Domain: Class III medical device · regulatory affairs.
    • 3–7 years' experience in regulatory affairs, quality assurance or related compliance roles within medical…
    • Co-ordinate, lead and develop the team of internationally based regulatory consultants engaged in global notification services (ca. 10 - 15 staff).
    • Basic medical/therapeutic area and medical terminology knowledge.
    • Basic knowledge of all applicable regional / national country regulatory guidelines and EC…
    • View all Thermo Fisher Scientific jobs - Remote jobs - Specialist jobs in Remote
    • Salary Search: Country Approval Specialist salaries in Remote
    • See popular questions & answers about Thermo Fisher Scientific
    • Strong understanding of medical terminology, statistical concepts, and relevant scientific and regulatory guidelines.
    • ION® Endoluminal Territory Associate reports to the ION® Endoluminal Program Manager (EPM).
    • This individual will be primarily focused on supporting early…
    • Private Medical Insurance package with additional medical cash plan scheme.
    • We're looking for someone with a degree in Life Sciences, *Human Factors or a…
    • Detailed knowledge of pre-contract and post-contract cost management, including estimating, cost planning, procurement, tendering, contract administration,…
    • Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual…
    • Partner with global and local medical affairs, clinical operations and cross-functional stakeholders to deliver post-trial managed access programs.
    • Regulatory Engagement: Lead interactions with regulatory bodies (FDA, EMA) regarding newly developed COAs designed to replace older declining in relevance COAs.
    • Deep knowledge of clinical trial contract management processes.
    • Partner with Quality Management to uphold high contract management and quality standards.
    • Own and maintain the Global Site Contracts Library, including country-specific contract templates, guidance documents, and supporting materials.
  • View similar jobs with this employer
    • This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and…
  • View similar jobs with this employer
    • Significant experience (typically 8+ years) within medical device industry.
    • Medical Devices: Advising on medical device quality and regulatory requirements,…
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
Let Employers Find YouUpload Your Resume