SGS

Global Head of Delivery and 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 including MDR and IVDR conformity assessment activities under SGS NB 1639.
  • Ensuring the effective performance of clinical, audits, technical, and product assessment functions.
  • Overseeing all technical teams, managing performance, and supporting the development of processes, systems, and personnel to meet business and regulatory objectives.
  • Ensuring compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements throughout assessment lifecycles.
  • Ensuring the team follows efficient allocation and utilization of technical resources across all conformity assessment activities.
  • Managing and promoting impartiality and conflict of interest policies across all teams (including subcontractors), ensuring independence of conformity assessment decisions.

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.
  • Fluency in English in addition to the local language.
Benefits
  • Flexible schedule and hybrid model.
  • SGS university and Campus for continuous 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 IVDRlead auditorproduct assessor
Soft Skills
leadershipinterpersonal skillsstakeholder managementorganizational skillschange managementcommercial understandingteam managementperformance managementconflict of interest managementindependence promotion
Certifications
Lead AuditorProduct AssessorFinal ReviewerDecision Maker