Makro provides complete range of solutions for every stage of the business and information lifecycle. From small enterprises with great products or solutions to Fortune 1000, Makro has the breadth of capabilities to support clients’ needs. Makro’s unique ability is to see the big picture. With experts in every aspect of life cycle, we offer several services to provide a comprehensive perspective on the challenges you face, and build innovative solutions to address them.
Post : Regulatory Associate
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 : 0-2yrs
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th January, 2018
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