Global Technical Manager – Sterilization (Remote)

About the role

SGS, a global testing, inspection and certification company, is hiring a Global Technical Manager for Sterilization. The role is fully remote and reports to the Head of Delivery & Operations. It oversees sterilization processes for medical devices and provides technical support across certification schemes such as MDR, MDD, UK MDR, ISO 13485, MDSAP and IVDR, while acting as line manager for the team of MDR Product Assessors – Sterilization.

Key responsibilities

• Provide technical advice on sterilization for all stages of the medical device conformity assessment process.
• Establish competence criteria, deliver and maintain training packages for Product Assessors and sterilization auditors, and manage their authorization, monitoring and re-approval.
• Develop and maintain sterilization QMS documentation for SGS NB 1639, aligned with best practices such as NBOG's BPG and MDCG guidance.
• Manage the team's workload, capacity and resource gaps, and drive performance against global targets including chargeability, utilization, productivity, timeliness, assessment quality and regulatory compliance.
• Act as a technical reference point for the team, Delivering Offices and Hubs, and resolve complex technical issues with minimal escalations.
• Contribute to business growth through proposals, client interactions, training and external engagements.

Required profile

• More than 10 years in the medical device industry, including at least 5 years in sterile device R&D, manufacturing or sterilization validation, plus QMS auditing and technical documentation assessment.
• 5 years as an MDR and/or IVDR Lead Auditor or Product Assessor – Sterilization within a Notified Body.
• 2 years of experience in a leadership role, with demonstrated technical decision-making and problem-solving.

Required skills

• Medical device management systems, compliance, auditing and technical documentation assessment.
• Knowledge of medical device legislation, harmonised standards, CS and guidance documents on sterilization.
• Knowledge of conformity assessment procedures and the Notified Body's quality management system.
• Ability to draw up records and reports showing conformity assessment activities were carried out correctly.
• Experience managing cross-functional global teams is an asset.