Aparna Kumar
Regulatory Affairs Specialist
About me
Seasoned professional specializing in Medical Device Regulation (MDR) remediation and ISO 13485–aligned Quality Management Systems (QMS). Experienced in compliance, audits, and continuous improvement to enhance product safety and quality. Strong collaborator with cross-functional teams, driving effective communication and project success.
Work Experience
Regulatory Affairs Specialist
Tata Elxsi
2024-04-01
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Present
Regulatory Affairs Specialist(MD)EUMDR|ISO13485|TDR|GSPRC|DoC|CE conformity assessment |IFU| Gap analysis |ISO 14971 & ISO 24971|DHF|Process & Sterilization validation| Regulation Disposable BMW|CEP & CER review
Education
Master of Engineering - MEng, Biomedical/Medical Engineering
Professional
2022-10-01
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2024-10-01
Agni College Of Technology
Grade: 8.75(CGPA)
Painpoints
Pls tick the issues faced in the previous interviews.
Not applicable
Open-To-Work
Are You Open To Work?
Definitely yes