Global Technical Manager – Sterilization

The role is fully remote and reports to the Head of Delivery & Operations

Main Purpose of Role

• Oversee sterilization processes within medical devices and provide technical support related to sterilization across all certification schemes - MDR, MDD, UK MDR, ISO13485, MDSAP, IVDR.
• Act as line manager and lead the team of MDR Product Assessors-Sterilization.
• Provide technical advice in relation to sterilization to support all stages of the medical device conformity assessment process
• Establish competence criteria, update, deliver and maintain appropriate training packages for Product Assessors (sterilization team) as well as sterilization auditors covering all certification schemes related to sterilization within the medical device conformity assessment process.
• Develop, maintain and implement sterilization QMS documentation related to medical devices conformity...