Chief Medical Devices Expert
3 days ago
The position requires a seasoned professional with 10 years of experience in healthcare products or related activities.
- Key responsibilities include assessing and auditing medical devices to ensure compliance with regulations such as ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
- Assessors must evaluate risk management processes using EN ISO 14971.
- A solid understanding of non-active devices and sterilization processes is also necessary.
- Good understanding of quality management principles
- Experience working with teams and contributing to their success
- Ability to analyze complex information and make informed decisions
This role involves collaborating with a team of assessors and auditors to achieve common goals.
Responsibilities OverviewThe role encompasses the following key responsibilities:
- Ensure medical device compliance with relevant regulations
- Evaluate risk management processes
- Maintain knowledge of non-active devices and sterilization processes
- Quality Management Principles
- Teamwork and Collaboration
- Analytical Skills
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