Global Technical Manager – Sterilization
Core
Lead a global team of MDR Product Assessors and sterilization auditors to oversee sterilization processes and provide technical support for medical device conformity assessments across MDR, MDD, UK MDR, ISO13485, MDSAP, and IVDR schemes.
Role type
Senior IC Technical Manager (Sterilization)
Builds
Medical device conformity assessment services and regulatory compliance for clients
Domain
Medical Devices / Regulatory Affairs / Sterilization
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device management systems, MDR/IVDR regulations, sterilization validation, QMS auditing, technical documentation assessment, competence management, team leadership, resource planning
Preferred skills
Cross-functional global team management, process improvement, business development support
Technologies
SGS NB 1639, MDCG guidance, NBOG BPG
Responsibilities
Manage and lead the team of MDR Product Assessors-Sterilization; Establish and maintain training packages for assessors and auditors; Develop and implement sterilization QMS documentation; Monitor team KPIs including chargeability, utilization, and assessment quality; Provide expert technical support and resolve complex regulatory issues; Support business development proposals and client interactions.
Seniority
Senior, hands-on IC with leadership responsibilities