SGS

Global Head of Operations

SGS

full-time

Posted on:

Location Type: Remote

Location: Italy

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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 the effective performance of clinical, audits, technical, and product assessment functions.
  • Drive operational excellence, regulatory compliance, and strategic resource management.
  • Oversee all technical teams, manage performance, and support development of processes, systems, and personnel.
  • Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements throughout assessment lifecycles.
  • Lead training and competence management strategies across technical 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.
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 assessmentQMS requirementsresource planningISO 13485MDSAPUKCAEU MDREU IVDRauditsproduct assessment
Soft Skills
leadershipinterpersonal skillsstakeholder managementorganizational skillschange managementstrategic resource managementoperational excellenceteam managementperformance managementtraining management
Certifications
Lead AuditorProduct AssessorFinal ReviewerDecision Maker