Global Technical Manager – Sterilization (Medical Devices)

Location: Fully remote; job location listed as Bucharest, Romania

Company

hirify.global is a global testing, inspection, and certification company operating offices and laboratories worldwide.

What you will do

• Oversee sterilization processes and provide technical support for medical device conformity assessments across MDR, MDD, UK MDR, ISO 13485, MDSAP, and IVDR.
• Lead the MDR Product Assessors–Sterilization team and manage workload planning, capacity, performance, and resource allocation across hubs and delivering offices.
• Provide expert technical guidance on sterilization, regulatory requirements, technical documentation, CE marking activities, client queries, and complex escalations.
• Develop, maintain, and implement sterilization procedures, QMS documentation, guidance materials, and internal and external training packages.
• Manage recruitment, competence assessment, qualification, authorization, monitoring, re-approval, appraisals, and performance management for technical personnel.
• Support proposals, client interactions, external engagements, operational targets, and continuous improvement initiatives.

Requirements

• More than 10 years of experience in the medical device industry, including at least 5 years in sterile medical device research and development or manufacturing.
• Experience with sterilization processes, microbial monitoring, packaging integrity, sterilization validation, QMS auditing, and technical documentation assessment.
• At least 5 years as an MDR and/or IVDR Lead Auditor or Product Assessor–Sterilization within a notified body.
• At least 2 years in a leadership role, with demonstrated technical decision-making and expert-level problem-solving.
• Experience in competence management, training, or qualification of technical personnel and in supporting global or cross-functional teams.
• University or technical college degree, or equivalent qualification, in microbiology, medicine, pharmacy, engineering, or a relevant science with microbiology modules; current or previous qualification as an MDR Product Assessor or MDR Lead Auditor is required.

Nice to have

• Experience working in a notified body or equivalent regulatory environment.
• Experience developing technical procedures or training programmes.
• Knowledge of hirify.global processes and quality management systems.
• Experience managing cross-functional global teams.

Culture & Benefits

• Fully remote role with a flexible schedule.
• International, multinational working environment with colleagues across multiple continents.
• Access to hirify.global University and Campus learning opportunities.
• Benefits platform and a focus on professional development, integrity, quality, safety, and continuous improvement.