SGS

Global Head of Operations

SGS

full-time

Posted on:

Location Type: Remote

Location: Germany

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Job Level

Lead

About the role

  • Leading and coordinating the operational delivery of all medical schemes
  • Ensuring effective performance of clinical, audits, technical, and product assessment functions
  • Overseeing all technical teams, managing performance, and supporting development of processes, systems, and personnel
  • Ensuring compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements
  • Managing technical certification activities, including resource allocation, technical KPI monitoring, and process improvements
  • Leading training and competence management strategies across technical teams
  • Supporting proactive recruitment, onboarding, and qualification of personnel involved in conformity assessment
  • Driving continuous improvement of technical workflows and quality management processes
  • Acting as key interface with regulatory authorities, accreditation bodies, and internal stakeholders
  • Monitoring and responding to regulatory changes, industry trends, and accreditation requirements
  • Managing and promoting impartiality and conflict of interest policies across all teams

Requirements

  • Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO13485 and MDD
  • Proven and solid leadership in managing cross-functional teams in regulated environments
  • Knowledge of conformity assessment procedures and QMS requirements
  • Excellent interpersonal and stakeholder management skills
  • Strong organizational and change management capabilities
  • Strong commercial understanding and appreciation of the TIC industry
  • Experience in resource planning
  • Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR
  • Qualification as Final Reviewer and Decision Maker under MDR or IVDR
  • Experience in a Notified Body or equivalent regulatory organization
  • 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
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
Applicant Tracking System Keywords

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

Hard Skills & Tools
conformity assessment proceduresQMS requirementstechnical KPI monitoringprocess improvementsresource planningdesign assessmentmanufacturing assessmentauditingtechnical documentation assessmentbudget management
Soft Skills
leadershipinterpersonal skillsstakeholder managementorganizational skillschange managementcommercial understandingteam managementperformance managementtraining managementconflict of interest management
Certifications
Lead Auditor under EU MDR/EU IVDRProduct Assessor under EU MDR/EU IVDRFinal Reviewer under MDRDecision Maker under IVDR