MakroCare is expert strategic development and commercialization global partner for pharmaceutical, biotechnology and medical device industries. Our experience, programs and processes bring a new dimension to development strategy, regulatory/risk planning & management, clinical research, medical/scientific support and emerging region expansion.
Post : Regulatory Associate
No of Posts : 04
Job Description
• 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.
Additional Information
Experience : 0-2 yrs
Location : Telangana, Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
Job Type : Permanent
End Date : 3/14/2019
Contact Person : Rajesh Neelam
Contact Email : rajesh.neelam@makrogrp.com
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