
Medical Device Assessment Lead
5 days ago
Job Overview
A seasoned professional is sought after to lead medical device assessments with expertise in quality management and risk mitigation.
About You
- With over a decade of experience in the healthcare industry, you have honed your skills in product development, manufacturing, and regulatory compliance.
- In addition to general industry knowledge, 5+ years of focused experience in quality management are necessary for this role.
Key Responsibilities
- Ensure meticulous adherence to regulatory standards including ISO 13485, MDD 93/42/EEC, and IMDR by leveraging deep understanding of these frameworks.
- Collaborate effectively with assessors/auditors, utilizing EN ISO 14971 risk management principles to drive results.
- Maintain up-to-date knowledge of non-active devices and sterilization processes.
Requirements
- Thorough understanding of ISO 13485, MDD 93/42/EEC, and IMDR regulations.
- Experience with Risk Management EN ISO 14971.
- Strong grasp of non-active devices and sterilization processes.
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