Job Description

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.

Main Purpose of Role

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.

Full ownership of operational frameworks, performance management, chargeability, competency systems, and operational risk management, ensuring the notified body including all medical schemes operates efficiently, compliantly, and profitably. This includes all Product Assessors, In House Clinicans, Auditors and their line managers, globally for all Medical Schemes.

At its core is operational excellence, systems, controls, and long‑term capability, enabling effective delivery and regulatory compliance.

Defined responsibilities, authorities and accountabilities

The role encompasses a wide range of responsibilities, including but not limited to the following:

• Directly 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 schemes certification activities including MDR, IVDR, ISO13485, MDSAP and UKCA.
• 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, working closely with Head of Delivery, Global Head of Medical Devices, Global Head of Sales and Business Development and 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 a key liaison for designation maintenance, accreditation activities, and regulatory inspections.
• Monitor and proactively respond to regulatory changes, capacity risks, and industry trends impacting operations.

Areas of accountability as member of the Global Leadership Team

• Member of the Global Medical Leadership team for Medical Devices, where proactive input, reporting or data must be delivered on a regular basis, within area or responsibilities.
• Drive and deliver projects proactively, without delay, within areas of responsibilities - taking full ownership from initiation through implementation.
• Own and lead processes, ensuring regulatory, commercial, and operational alignment – within areas of responsibility.
• Lead continuous improvement initiatives, within area of responsibilities, across Medical Devices.
• Collaborate closely with relevant line managers across the business, to ensure seamless handover from contract review to delivery.
• Support recruitment, onboarding, qualification, and competence management of personnel within area of responsibilities.
• Ensure teams operate in full compliance with SGS integrity policies, impartiality requirements, and confidentiality obligations.
• Maintain strong relationships with internal and external stakeholders and contribute to regulatory and accreditation readiness activities.
• Secure adequate resources for conformity assessment activities across all Medical schemes, within areas of responsibilities.
• Drive standardisation and harmonisation of processes across schemes and regions – within areas of responsibilities.
• Accountable for the activities and decisions taken by the notified body, including contractual agreements.

Qualifications

Skills & Knowledge

• 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.

Experience

• 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.

Qualifications

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

The role can be fully remote and we are open to consider candidates located across Europe (with valid work permit). Please kindly write your CV in English

Additional Information

Why SGS?

• Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• SGS university and Campus for continuos learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

Join Us: At SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.