EU MDR Licensed Operations Head

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 all Medical Schemes
• Optimize the operating model for certification activities including MDR, IVDR, ISO13485, MDSAP, and UKCA
• Manage operational performance, financial performance, and resource strategy while ensuring compliance and risk management

Required Qualifications, Training, and Education

• 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
• In-depth knowledge of EU MDR, EU IVDR, UKCA, MDSAP, and ISO 13485 operational requirements