
Medical Devices Specialist
6 days ago
Objective:
Assess and manage medical devices to ensure compliance with regulatory standards.
Key Responsibilities:
- Conduct audits and assessments of medical devices against ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, MDSAP, and IMDR standards.
- Manage risks associated with medical devices using EN ISO 14971 and demonstrate expertise in non-active devices and sterilization processes.
- Work collaboratively with a team of assessors/auditors to achieve common goals through effective communication and teamwork skills.
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