Global Team Leader - Ivdr

SGS Australia Pty Ltd

Wrexham, United Kingdom
Remote
In vitro diagnostics certification processes
Technical lead and expertise
Ivdr product assessors
In conjunction with Global Head of Certification and compliance and QA & RA Manager, liase with regulatory authorities and other certification bodies on all technical/regulatory questions to ensure the integrity and compliance of all in vitro diagnostics certification processes and decisions

Job Summary

  • In conjunction with Global Head of Certification and compliance and QA & RA Manager, liase with regulatory authorities and other certification bodies on all technical/regulatory questions to ensure the integrity and compliance of all in vitro diagnostics certification processes and decisions.
  • Provide technical lead and expertise to the global Medical Devices network, including the sales and commercial teams, relating to in vitro diagnostic medical device certification, as well as the respective medical device scheme managers (ISO13485, MDSAP, UKCA).
  • The role can be fully remote and we are open to consider candidates located accros Europe (with valid work permit).

Matching Summary

In conjunction with Global Head of Certification and compliance and QA & RA Manager, liase with regulatory authorities and other certification bodies on all technical/regulatory questions to ensure the integrity and compliance of all in vitro diagnostics certification processes and decisions.

Skills & Requirements

Must-have

  • in vitro diagnostics certification processes
  • technical lead and expertise
  • IVDR product assessors
  • QMS documentation for medical devices
  • conformity assessment procedures
  • medical device management systems

Nice-to-have

  • open corporate and international culture
  • future-oriented work environment
  • stakeholder management skills
  • cross functional global teams

Key Requirements

  • Four years professional experience in the TIC industry
  • Two years in design, manufacture, testing or use of device
  • Management experience of global teams
  • University or technical college degree or equivalent

Work Rights

Valid work permit for Europe

Tailored Resume

Cover Letter