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.
• Directly lead all line managers in Operations heading up the Product Assessors, Auditors and In House Clinicians for all Medical Schemes.
• Maintain and optimise the operating model supporting all Medical schemes certification activities.
• Oversee operational performance management, including KPIs, dashboards, capacity models, and reporting
• including Global Medical Devices, DOs and Hubs.
• 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.
• Monitor and proactively respond to regulatory changes, capacity risks, and industry trends impacting operations.

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.
• Demonstrated success in scaling operations and improving operational performance.
• Experience working within a Notified Body or equivalent regulatory organisation.
• 5+ years experience in Notified Body, manufacturing or other regulated industries.
• 5+ years leadership experience.
• Qualification as Lead Auditor or Senior Product Assessor under EU MDR/EU IVDR.
• Qualification as Final Reviewer and/or Decision Maker under MDR or IVDR, desirable.
• University degree in medicine, engineering, or life sciences.

Benefits

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