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SGS

When you need to be sure

Global Head of Operations

OperationsOperationsFull TimeRemoteLeadTeam 10,001+Since 1878H1B SponsorCompany SiteLinkedIn

Location

Spain

Posted

103 days ago

Salary

0

Seniority

Lead

Bachelor Degree10 yrs expEnglish

Job Description

Global Head of Operations

SGS

• 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.

Job 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

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