
Senior Medical Devices Specialist
2 days ago
Job Opportunity:
">We are seeking a seasoned professional to fill the role of Medical Devices Assessor/Auditor.
The ideal candidate will have extensive experience in quality management and medical devices, with a focus on ensuring compliance with regulatory requirements.
- Main Responsibilities:
- Audit and assess medical devices to ensure adherence to regulatory standards such as ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations
- Develop risk management strategies utilizing EN ISO 14971 guidelines
- Collaborate with a team of professionals to achieve common objectives
- Maintain up-to-date knowledge of regulatory standards and industry best practices
Key Qualifications:
- At least 10 years of experience in the medical devices industry or related field
- 5+ years of experience in quality management is essential
- Detailed understanding of non-active devices and sterilization processes
- Strong comprehension of regulatory standards and industry best practices
What We Offer:
A challenging and rewarding career opportunity in a dynamic work environment, with opportunities for growth and professional development.
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