Global Team Leader - Ivdr

SGS Australia Pty Ltd

Warszawa, Poland
Remote
In vitro diagnostics certification processes
Technical lead and expertise
Conformity assessment process
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.
  • Lead the team of IVDR product assessors and IVDR IHC. Support the Training and Competency Manage and CV reviewer in conformity assessment and CV review.
  • 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
  • conformity assessment process
  • QMS documentation development
  • regulatory authorities liaison
  • medical device scheme managers

Nice-to-have

  • open corporate and international culture
  • future-oriented work environment
  • dynamic work environment
  • stakeholder management skills

Key Requirements

  • Four years professional experience in TIC
  • Two years in design, manufacture, testing or use
  • University or technical college degree
  • Management experience of global teams
  • Strong and proven project management skills

Work Rights

Not specified

Tailored Resume

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