EU MDR Certified Operations Leader

Job Summary

A company is looking for a Global Head of Operations.

Key Responsibilities

• Lead line managers overseeing Product Assessors, Auditors, and In House Clinicians for Medical Schemes
• Maintain and optimize the operating model for certification activities including MDR, IVDR, ISO13485, MDSAP, and UKCA
• Oversee operational performance management, including KPIs, capacity models, and financial performance

Required Qualifications

• Minimum 10 years' experience in the medical device or IVD industry
• At least 5 years in a technical leadership role within a Notified Body
• University degree in medicine, engineering, or life sciences
• Qualification as Lead Auditor or Senior Product Assessor under EU MDR/EU IVDR
• Proven experience in scaling operations and improving operational performance