SGS

Global Head of Operations

SGS

full-time

Posted on:

Location Type: Remote

Location: Spain

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Job Level

Lead

About the role

  • Leading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639.
  • Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements throughout assessment lifecycles.
  • Operational management of technical certification activities, including resource allocation, technical KPI monitoring, and process improvements.
  • Drive continuous improvement of technical workflows, IT systems supporting assessment, and quality management processes to enhance efficiency and service quality.
  • Act as key interface with regulatory authorities, accreditation bodies, and internal stakeholders to maintain SGS reputation, designations, accreditations and compliance.

Requirements

  • Minimum 10 years in the medical device or IVD industry, including experience in design, manufacturing, auditing, or technical documentation assessment.
  • At least 5 years senior leadership in a Notified Body managing technical employees.
  • Minimum 2 years in revenue-focused leadership roles, including full profit and loss (P&L) accountability, budget management, and financial reporting.
  • Fluency in English in addition to the local language.
  • Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR.
  • Qualification as Final Reviewer and Decision Maker under MDR or IVDR.
Benefits
  • Flexible schedule and hybrid model
  • SGS university and Campus for continuos learning options
  • Benefits platform
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
MDR conformity assessmentIVDR conformity assessmentISO 13485 complianceMDSAP complianceUKCA complianceEU MDR complianceEU IVDR compliancetechnical documentation assessmentbudget managementfinancial reporting
Soft Skills
leadershipoperational managementresource allocationprocess improvementcommunicationstakeholder managementcontinuous improvementinterface with regulatory authoritiesteam managementKPI monitoring
Certifications
Lead Auditor under EU MDR/EU IVDRProduct Assessor under EU MDR/EU IVDRFinal Reviewer under MDRDecision Maker under IVDR