Sidhant Mishra Email & Phone Number
Who is Sidhant Mishra? Overview
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Sidhant Mishra is listed as Regulatory Affairs Associate at Johnson & Johnson MedTech, a with 36068 employees, based in New Delhi, Delhi, India. AeroLeads shows a matched LinkedIn profile for Sidhant Mishra.
Sidhant Mishra previously worked as Scientific and Regulatory Affairs Associate at Regulatory Wisdom and Research Analyst at Synzeal Research Pvt Ltd. Sidhant Mishra holds M Pharm from Parul University.
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About Sidhant Mishra
As Scientific and Regulatory Affairs Associate specializing in Medical Devices and IVDs, I bring extensive expertise in navigating regulatory frameworks. My in-depth knowledge of MDR 2017 combined with hands-on experience in licensing and labeling ensures compliance and smooth product approval processes. Having successfully worked on multiple projects utilizing these skills, including registrations across different classes of medical devices on government portals like CDSCO MD and NSWS, as well as managing registrations for price regulations on IPDMS 2.0 and compliance as per BIS. I've spearheaded initiatives that have streamlined regulatory procedures, optimizing efficiency and enhancing organizational outcomes.
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Sidhant Mishra work experience
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Scientific And Regulatory Affairs Associate
• Developing thorough strategies to penetrate the medical device and IVD markets in India, while ensuring alignment with MDR 2017 regulations.• Experienced in risk class evaluation of medical devices and IVDs, predicate device identification, and medical device grouping• Skilled in filing various medical device applications (MD 3, MD 4, MD 12, MD 14, MD 16, MD41)• Developed and reviewed label texts & Artworks/Labels (Global & India Specific) to ensure compliance with MDR 2017, Legal Metrology Act, Plastic Waste Management Rules.• Well-versed in the Medical Devices Rules, 2017, and adept at utilizing the CDSCO MD Portal and NSWS Portal for regulatory compliance.• Registered multiple medical devices on the IPDMS portal in accordance with the latest DPCO 2013 and NPPA regulations.• Effectively communicated with regulatory agencies (e.g., CDSCO, USFDA) to address inquiries, resolve potential issues, and facilitate smooth regulatory processes.• Create monthly newsletters on medical devices & IVDs, highlighting the latest regulatory updates.• Skilled in identifying relevant BIS standards for medical devices and facilitating BIS registrations as per regulatory requirements.• Experienced in developing and preparing Clinical Evaluation Performance Plans for medical devices in accordance with regulatory guidelines.• Proficient in identifying and assigning GMDN and UMDN codes for various medical devices.
Research Analyst
Sidhant Mishra education
M Pharm
Bachelor Of Pharmacy - Bpharm, Pharmacy
Secondary Education
Class X
Frequently asked questions about Sidhant Mishra
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What company does Sidhant Mishra work for?
Sidhant Mishra works for Johnson & Johnson MedTech.
What is Sidhant Mishra's role at Johnson & Johnson MedTech?
Sidhant Mishra is listed as Regulatory Affairs Associate at Johnson & Johnson MedTech.
Where is Sidhant Mishra based?
Sidhant Mishra is based in New Delhi, Delhi, India while working with Johnson & Johnson MedTech.
What companies has Sidhant Mishra worked for?
Sidhant Mishra has worked for Johnson & Johnson Medtech, Regulatory Wisdom, and Synzeal Research Pvt Ltd.
How can I contact Sidhant Mishra?
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What schools did Sidhant Mishra attend?
Sidhant Mishra holds M Pharm from Parul University.
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