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.
Contribute to the day-to-day management and business development of the in vitro diagnostic medical devices activities to achieve defined operational and financial targets and maintain both technical and regulatory compliance.
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 diagnostic medical device certification
regulatory authorities and certification bodies
ISO13485, MDSAP, UKCA schemes
conformity assessment process
QMS documentation development
medical device management systems
Nice-to-have
open corporate and international culture
future-oriented work environment
stakeholder management skills
clinical application of technology understanding
Key Requirements
Four years professional experience in TIC industry
Two years in design, manufacture, testing or use of device
Management experience of global teams
University or technical college degree in relevant sciences