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 position reports to the Head of Delivery & Operations and offers a dynamic work environment in a leading global company.
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
medical device scheme managers
IVDR product assessors
conformity assessment
medical device management systems
harmonised standards
Nice-to-have
open corporate and international culture
dynamic work environment
future-oriented work environment
cross functional global teams
Key Requirements
Four years professional experience in TIC
Two years in design, manufacture, testing or use of device