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Job Id
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181103
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Title
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Regulatory Associate
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Job Type
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Permanent
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Duration
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City
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Hyderabad
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State
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Telangana
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Zip
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Job Description
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- Serves as an Associate RA representative on project team
- Supports senior Regulatory personnel in preparing new product marketing submission for the FDA (510k, PMA)
- Maintains Regulatory Affairs documentation & support international Regulatory requests
- Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data
- Provide support to currently marketed products & assit on change requests, etc.
- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations
- Evaluate the safety, efficiency, and effectiveness of biomedical equipment
- Perform analysis of data collected, root-cause sources of error in measurements, implement improvements in hardware, measurement methods, or signal processing
- Liaising with medical, engineering & scientific staff, literature search expert
- Train clinicians, life scientists, chemists, medical scientists and other personnel on engineering aspects of biological systems of humans and animals on the proper use of equipment.
- Basic understanding of FDA and EU regulatory process for different class devices.
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Qualification
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Certification/Licensure
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Experience
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0-2yrs
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Job Category
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Regulatory Affairs
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Posted On
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11/14/2018
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Expires On
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3/14/2019
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