Job Description

Job Id   181103
Title   Regulatory Associate
Category   Regulatory Affairs
Job Status   Full Time
Job Type   Permanent
No of Openings   4
Salary   
Region   Asia Pacific
Country   India
State   Telangana
City   Hyderabad
Zip   
Posted On   11/14/2018
Expires On   3/14/2019
Years of Experience   0-2yrs
Contact Person   Rajesh Neelam
Contact Email   rajesh.neelam@makrogrp.com
Contact Number   
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.
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