Sterilisation Specialist

The Consultant will lead and support sterilisation strategy, validation, and compliance activities across the full lifecycle of medical devices, including implantable Class II/III products. The role requires deep expertise in sterilisation modalities, microbiological testing, and regulatory frameworks under both FDA and EU MDR.

The role requires deep expertise in sterilisation modalities, microbiological testing, and regulatory frameworks under both FDA and EU MDR.

Job Title: Sterilisation Expert

Duration: 12 months (with extension opportunity)

Hours: 20 hours a week (hybrid/remote)

Location: Barcelona, Spain

Key Responsibilities:

• Sterilisation Strategy & Validation
• Develop and execute sterilisation validation plans using Ethylene Oxide (EtO), steam, radiation, and other methods.
• Ensure compliance with ISO 11135, ISO 11137, ISO 17665, ISO 14937, ISO 11737-1/-2, and EN 556-1 standards.
• Oversee cleanroom validation and bioburden/endotoxin testing protocols.
• Regulatory Compliance
• Align sterilisation processes with FDA 21 CFR Part 820 and EU MDR 2017/745 Annex I and VIII.
• Prepare documentation for CE marking, FDA submissions, and Notified Body audits.
• Support risk management activities per ISO 14971 and ISO 13485.
• Technical Support & Troubleshooting
• Lead root cause investigations for sterilisation failures and non-conformities.
• Advise on parametric release strategies and alert/action levels for cleanroom and microbiological monitoring.
• Cross-functional Collaboration
• Interface with R&D, manufacturing, and external sterilisation providers.
• Review and approve sterilisation protocols, reports, and supplier QMS certificates.
• Training & Knowledge Transfer
• Deliver internal training sessions on sterilisation standards and regulatory expectations.
• Mentor junior QA/RA staff on validation and documentation best practices.

Required Qualifications:

• Advanced degree in microbiology, biomedical engineering, or related field.
• Minimum 8 years of experience in medical device sterilisation and regulatory affairs.
• Proven track record with Class III implantable and complex device configurations.
• Familiarity with ISO/AAMI/ASTM standards and FDA guidance documents.
• Strong documentation, analytical, and communication skills.