Randstad

Technical Writer - Medical Devices (BB-6CC5C)

Found in: Neuvoo UK

Description:

Location: Remote

Pay rate: £40-£50ph

Contract: 6 months

Are you an experienced Technical Writer for medical devices? Have you had experience as a Technical Writer for software in a highly regulated industry? Are you experienced working with FDA, MDR, ISO13485, ISO62304 or SaMD?

We are recruiting for a Technical Writer to join on a contractor basis for a global healthcare organisation. The successful person will be instrumental in the registering of software as medical devices with global authorities.

Responsibilities:

  • Under general supervision, researches, writes, and edits product design documentation, procedures, work instructions and manuals in support of Quality Assurance, Engineering and Operations functions.
  • Writing technical design documents for medical device products, manufacturing, research, or quality assurance
  • Be part of the project to remediate design documents as part of new QMS
  • Help engineering team to author intent for use audience statement and help out with background design documentation.
  • Working with the change control process.
  • Complete documentation to register software as medical device with national authorities
  • Translate technical information and system requirements into content that is comprehensible by the end user
  • Work actively with product management, quality management and regulatory to ensure alignment between user needs and documentation.
  • Key Requirements:

  • Demonstrated success in Technical writing in the healthcare industry or another regulated industry.
  • Experience in Quality Assurance/ Regulatory requirements in medical devices, pharmaceuticals, medical devices.
  • Strong experience owning end-to-end documentation creating process.
  • Experience working on documentation such as intended use, instructions for use and labelling for Medical devices.
  • Software as a Medical Device (SaMD) experience is an advantage
  • Please apply with an up to date CV today!

    Randstad Business Support is acting as an Employment Business in relation to this vacancy.

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