Global Team Leader - IVDR
Core
Lead the team of IVDR product assessors and IHC to ensure integrity and compliance of in vitro diagnostics certification processes, liaising with regulatory authorities and providing technical expertise to the global medical devices network.
Role type
Senior Team Leader, In Vitro Diagnostic Medical Device Conformity Assessment
Builds
IVDR certification decisions and conformity assessment services for in vitro diagnostic medical devices
Domain
Medical Devices / Regulatory Compliance / In Vitro Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IVDR regulatory knowledge, ISO13485/MDSAP/UKCA scheme management, team leadership, project management, stakeholder management, QMS documentation, technical review of conformity assessment
Preferred skills
Broad range of competency codes, understanding of clinical application of technology
Technologies
MDCG guidance documents, SGS NB 1639 procedures
Responsibilities
Liaise with regulatory authorities on technical/regulatory questions, lead IVDR product assessor and IHC teams, develop and maintain training packages for assessors, manage training processes for new and existing personnel, provide technical advice on conformity assessment stages, develop and implement QMS documentation, establish competence criteria for technical experts, support business development and operational targets
Seniority
Senior, hands-on IC with management responsibilities