ApplyIVD / IVDR Advisor
Posted 3 months agoInactiveViewed
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💎 Seniority level: Senior, 5+
📍 Location: Europe
🔍 Industry: Healthcare, diagnostic laboratories
🏢 Company: Platomics GmbH
🗣️ Languages: English, German, Italian, French
⏳ Experience: 5+
🪄 Skills: Project ManagementRisk Management
Requirements:
- 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.
Responsibilities:
- 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.
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