Global Head of Operations

Role Overview

• Accountable for the full operational oversight, governance, scalability, and sustainability of SGS NB 1639 medical device and IVD activities
• Full ownership of operational frameworks, performance management, chargeability, competency systems, and operational risk management
• Directly lead all line managers in Operations heading up the Product Assessors, Auditors and In House Clinicians
• Maintain and optimise the operating model supporting all Medical schemes certification activities
• Oversee operational performance management, including KPIs, dashboards, capacity models, and reporting
• Accountability for cost management, and operational financial performance
• Lead resource strategy, including capacity modelling, subcontractor strategy, and long-term workforce planning
• Develop and maintain competence management, training frameworks, and qualification pathways for all operational roles
• Proactively manage operational risks, escalation processes, and business continuity planning
• Act as a key liaison for designation maintenance, accreditation activities, and regulatory inspections

Requirements

• Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO 13485, and notified body operational requirements
• In-depth knowledge of conformity assessment delivery models and processes
• Proven experience building and managing teams in a highly regulated environment
• Expertise in capacity planning, resource optimisation, and performance management
• Excellent organisational, analytical, and change-management skills
• Excellent stakeholder management and communication skills
• Ability to balance regulatory compliance with business efficiency
• Experience within a Notified Body or equivalent conformity assessment organisation
• Minimum 10 years’ experience in the medical device or IVD industry
• At least 5 years in a technical leadership role within a Notified Body
• Qualification as Lead Auditor or Senior Product Assessor under EU MDR/EU IVDR
• University degree in medicine, engineering, or life sciences

Benefits

• Flexible schedule and hybrid model
• SGS university and Campus for continuous learning options
• Multinational environment where you will work with colleagues from multiple continents