Purva Mahale

Regulatory Affairs Specialist @Biorad Medisys

Pune, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Oct 2023 — Present

Regulatory Affairs Specialist @Biorad Medisys

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Pune, IN

EDUCATION

N/A

Institute Of Business Management and Research

Master of Business Administration - MBA, Marketing

N/A

Savitribai Phule Pune University

Master of Science - MSc, Microbiology, General

N/A

Gokhale Edcuation Societys H.P.T.Arts & R.Y.K.Science College, Vidyanagar, Nashik 422005

Bachelor of Science, Microbiology, General

ABOUT PURVA MAHALE

As a regulatory affairs professional, I bring a wealth of knowledge and expertise in navigating the complex landscape of regulatory compliance in pharmaceutical and medical industry. In addition, I possess a understanding of quality management systems (ISO 9001:2015), including ISO 13485:2016, and have successfully managed audits and inspections by regulatory agencies. I am also well-versed in regulatory compliance for manufacturing license application for medical devices and pharmaceuticals and WHO-GMP.I also have worked on Risk management (ISO 14971) and Post Marketing Surveillance for medical device. With my broad range of skills and experience, I am confident in my ability to provide effective regulatory compliance solutions and support for any company operating in the medical device and pharmaceutical industry.

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Purva Mahale — Regulatory Affairs Specialist at Biorad Medisys in Pune, IN | Unifers