Global Technical Manager – Sterilization (Medical Devices)

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.
• Develop and maintain sterilization QMS documentation for SGS NB 1639, aligned with best practices such as NBOG's BPG and MDCG guidance.
• Manage the development, approval and ongoing monitoring and re-approval of personnel, including Hubs and DO resources.
• Drive team performance against global targets, including chargeability, utilization, productivity, timeliness, assessment quality and regulatory compliance.
• Act as a technical reference point for the team, DOs and Hubs, resolve escalations proactively and contribute to business growth through proposals and client interactions.
• Perform annual appraisals and support corrective actions, and monitor team KPIs.

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 in a Notified Body.
• 2 years of experience in a leadership role, with experience managing cross-functional global teams.
• Must be or have previously been a qualified MDR Product Assessor and/or MDR Lead Auditor.
• University or technical college degree in microbiology, medicine, pharmacy, engineering or a relevant science.
• Previous experience in a Notified Body or equivalent regulatory environment is desirable.

Required skills

• Knowledge of medical device management systems, compliance, auditing and technical documentation assessment.
• Understanding of medical device legislation, harmonised standards and sterilization guidance.
• Competence management, training and qualification of technical personnel.

What we offer

• Flexible schedule and hybrid model.
• University and campus learning options.
• Benefits platform.