EU MDR Licensed Operations Director

Job Summary

A company is looking for a Global Head of Operations.

Key Responsibilities

• Lead and manage technical functions for all medical schemes globally, ensuring compliance with relevant standards
• Oversee operational management of technical certification activities, including resource allocation and process improvements
• Act as a key interface with regulatory authorities and internal stakeholders to maintain compliance and uphold the company's reputation

Required Qualifications

• University degree in medicine, engineering, life sciences, or a related field
• Minimum 10 years of experience in the medical device or IVD industry
• At least 5 years of senior leadership experience in a Notified Body
• Minimum 2 years in revenue-focused leadership roles with P&L accountability
• Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR