IVD / IVDR Advisor

Posted 4 days agoViewed

💎 Seniority level: Senior, 5+

📍 Location: Europe

🔍 Industry: Healthcare, diagnostic laboratories

🗣️ Languages: English, German, Italian, French

⏳ Experience: 5+

🪄 Skills: Project ManagementRisk Management

Comprehensive knowledge of ISO 15189, IVDR, and quality management systems.
5+ years of practical experience with in-house EU-IVD devices, including validation.
Strong risk management and project management skills.
Ability to communicate complex concepts clearly.
Degree in Life Sciences or related field.

Guide diagnostic laboratories through regulatory compliance for ISO 15189 and IVDR.
Leverage automation technology to streamline technical documentation and SOPs.
Conduct workshops and individual sessions on regulatory processes.
Stay updated on regulatory changes and contribute to service development.

Posted 4 days ago

📍 Europe

🔍 Healthcare, Diagnostic Laboratories

Comprehensive knowledge of ISO 15189, IVDR, and quality management systems.
5+ years of practical experience with in-house EU-IVD devices, including validation and performance evaluation.
Strong risk management and project management skills.
Ability to explain complex concepts clearly.
Strong written and oral English communication skills.
Degree in Life Sciences or a related field.
Proficiency in working within a digital, paperless environment.

Provide expert guidance on IVD/IVDR compliance to diagnostic laboratories.
Navigate regulatory standards such as ISO 15189 and IVDR.
Leverage an automation platform to streamline technical documentation and QMS functions.
Conduct workshops and individual sessions for implementing necessary processes.
Stay updated on regulatory changes and technological advancements.

Risk Management

Posted 4 days ago

🔧 Requirements