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Principal Medical Devices Specialist
3 weeks ago
Job Title: Senior Device Engineer
Job Description:The ideal candidate will possess a strong background in medical devices, with experience in quality management and regulatory affairs.
- At least 10 years of professional experience in the healthcare products industry or related activities, including research and development, manufacturing, and quality management are required.
- 5+ years of relevant professional experience in quality management is essential.
Key Responsibilities:
- Assess and audit medical devices to ensure compliance with ISO standards, MDD regulations, Indian Medical Device Regulations, and MDR 2017/745.
- Develop and implement risk management strategies using EN ISO 14971.
- Collaborate with a team of assessors/auditors to work on various projects.
Requirements:
- Good knowledge of sterilization processes and non-active devices is necessary.
- Ability to work effectively in a team environment is crucial.
