Job Description
We are currently seeking a highly skilled IVDR Consultant with expertise in Clean Ops / CPS (cleaning system Process – Refers to a controlled cleaning system or protocol used to ensure the cleanliness of equipment, surfaces, or critical environments, in compliance with quality standards (e.g., ISO 13485, GMP). CPS Cleaning would therefore refer to cleaning activities carried out according to validated procedures, which are critical in sterile environments or to prevent cross-contamination) Cleaning processes to support a remote project in the life sciences sector. This role will involve building and delivering a comprehensive training program, developing user documentation, and addressing compliance and quality requirements aligned with IVDR standards.
Key Responsibilities
- Design and implement a training framework covering Clean Ops and CPS Cleaning under IVDR guidelines.
- Develop comprehensive documentation to support user understanding and ensure regulatory alignment.
- Deliver training sessions to end-users, with a focus on compliance, gap assessment, and operational best practices.
- Provide guidance on ethical committee interactions and related procedural knowledge.
- Collaborate with Senior Managers and cross-functional teams to ensure seamless integration of compliance requirements.
- Support quality assurance initiatives and documentation standards in accordance with regulatory expectations.
Requirements
- Proven experience with IVDR (In Vitro Diagnostic Regulation) implementation or support projects.
- Solid understanding of Clean Ops / CPS Cleaning procedures within a regulated environment.
- Familiarity with ethics committee processes and documentation requirements.
- Experience in quality assurance and/or compliance is a strong asset.
- Ability to build training content, deliver remote sessions, and adapt materials for diverse audiences.
- Strong analytical skills for gap analysis and risk-based compliance assessment.
- Excellent communication and documentation skills in English (written and spoken).
- Must be based in Europe and available to start by the end of May 2025.
- Language: English (fluent)
Nice to Have
- Previous experience in medical devices, diagnostics, or pharmaceutical industries.
- Knowledge of Good Documentation Practices (GDP), ISO standards, or GxP.
Remote: IVDR Consultant – Clean Ops (237193)
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