Global Head of Operations

Company Overview

SGS – the world's leading testing, inspection and certification company, recognised as the global benchmark for sustainability, quality and integrity.

Job Purpose

Accountable for the full operational oversight, governance, scalability and sustainability of SGS NB 1639 medical device and IVD activities, and all other Medical Schemes including MDSAP, ISO13485 and UKCA.

Key Responsibilities

• Lead all line managers in Operations heading up the Product Assessors, Auditors and In House Clinicians for all Medical Schemes, including Delivering Offices (DOs) and Hubs.
• Maintain and optimise the operating model supporting all Medical scheme certification activities, including MDR, IVDR, ISO13485, MDSAP and UKCA.
• Oversee operational performance management, including KPIs, dashboards, capacity models and reporting for Global Medical Devices, DOs and Hubs.
• Account for cost management and operational financial performance, working closely with Finance teams for Medical Devices.
• Lead resource strategy, including capacity modelling, subcontractor strategy and long‑term workforce planning, with input from Delivery and Sales.
• 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 key liaison for designation maintenance, accreditation activities and regulatory inspections.
• Monitor and respond to regulatory changes, capacity risks and industry trends impacting operations.

Areas of Accountability

• Member of the Global Medical Leadership team for Medical Devices, reporting regular data and findings.
• Drive and deliver projects from initiation through implementation.
• Own and lead processes ensuring regulatory, commercial and operational alignment.
• Lead continuous improvement initiatives across Medical Devices.
• Collaborate with line managers to ensure seamless handover from contract review to delivery.
• Support recruitment, onboarding, qualification and competence management of personnel.
• Ensure teams operate in full compliance with SGS integrity policies, impartiality requirements and confidentiality obligations.
• Build and maintain strong relationships with internal and external stakeholders and support regulatory and accreditation readiness activities.
• Secure adequate resources for conformity assessment activities across all Medical schemes.
• Drive standardisation and harmonisation of processes across schemes and regions.
• Accountable for the activities and decisions of the notified body, including contractual agreements.

Skills, Knowledge and Experience

• 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 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.
• 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 is desirable.
• University degree in medicine, engineering or life sciences.

Location and Working Arrangement

The role can be fully remote and we are open to consider candidates located across Europe (with valid work permit).

Benefits

• Global and very stable company, world leader in the TIC industry.
• Flexible schedule and hybrid model.
• SGS university and campus for continuous learning options.
• Multinational environment with colleagues from multiple continents.
• Benefits platform.