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.
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.
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.