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Rama D is listed as Regulatory Affairs| Women Who Empower Innovator Awardee 2024 | Lean Six Sigma Yellow Belt Certified | HIPAA Certified| Huntington 100 |Ex- IBM'er |Agile Star Awardee at Cresilon, a with 41 employees, based in Boston, Massachusetts, United States. AeroLeads shows a matched LinkedIn profile for Rama D.
Rama D previously worked as Regulatory Affairs Associate at Cresilon and Regulatory Affairs Intern at Cresilon. Rama D holds Masters, Regulatory Affairs, 3.97/4 from Northeastern University.
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A Regulatory enthusiast with proven skills and knowledge in aspects like understanding FDA regulations, regulatory writing, Regulatory Compliance, Regulatory documentation, Strategic Product development- Investigational Application for both drugs & and biologics, Understanding of concepts including safety sciences, Human experimentation, Medical Devices, Pharmaceuticals, therapeutic product development, Project Management, Clinical Trials, Clinical Research, and Management Legal issues: International Food, Drug, & Medical Device Regulations, GxP (GMP, GCP, GLP, GDP, and GTP (Good Tissue Practice)), thorough understanding of IRB, ICH, FDA, and EU guidance.As a part of my curriculum, I completed these assignments and prepared the informed consent form (ICH) template, FDA Meeting Request template, therapeutic product development (stages involved in the product development process), hypothetical product development process (from discovery to post-market research) named "magic dust," DUSR, Initial Pediatric Study Plan (IPSD), and medical device product development of any device of choice. worked on several case studies like BKK, Remdesivir, Alnylam, and Polio, to name a few.I'm looking forward to utilizing my skills and exploring and upgrading in the field of regulatory affairs.
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New York City Metropolitan Area
Regulatory Strategy (USFDA)Regulatory OperationsRegulatory Intelligence (Product Strategy & Development)Medical Device ReportingState LicensingGlobal Regulatory Strategies (MENA, EU)Regulatory Submissions
New York City Metropolitan Area
Medical Device Reporting, eSubmitter process, Adverse event reporting, Post Market Surveillance, Recall Procedure and Complaint handling procedures.
Boston, Ma
Regulatory Strategist Regulatory Intelligence Regulatory writing Let’s talk Regulatory!
Brooklyn, New York, United States
As a regulatory intern, I have contributed to the design of the regulatory pathway for Cresilon devices.Gained hands-on experience:Creating standard operating procedures (SOP)Regulatory Pathway designPre-submission PacketsDe Novo pathway Quality Management System: ISO 13485Special controls for a class II device.Thorough knowledge and understanding of the product codes of hemostatic devices in the US market.Comparative matrix of competitor products and their special controls.Labeling procedures as per 21 CFR 801.Unique device identifier: 21 CFR 830Understanding of the promotional material design approval process.Understanding of labeling approval and the design process.510k Decision-Making Flowchart.
Boston, Massachusetts, United States
Other employees you can reach at cresilon.com. View company contacts for 41 employees →
Caline Fernandes
Colleague at CresilonNew York, United States
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Kevin Stein
Colleague at CresilonBrooklyn, New York, United States
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Ignace Vallejo
Colleague at CresilonBrooklyn, New York, United States
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Eric Gayzler
Colleague at CresilonNew York City Metropolitan Area, United States
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Christopher Moore
Colleague at CresilonBrooklyn, New York, United States
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Zachary Hall
Colleague at CresilonDes Moines Metropolitan Area, United States
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Shrinivas Handigol
Colleague at CresilonNew York City Metropolitan Area, United States
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Dipti Ravi
Colleague at CresilonNew York, United States
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Nicholas Tarallo
Colleague at CresilonBrooklyn, New York, United States
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Matthew Lewis
Colleague at CresilonBrooklyn, New York, United States
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Activities and Societies: Kaizen Group, CHRM, Management Meets, Presentations, HR Mission Talent Test and so on..Distinction with 8.31/10.
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Rama D works for Cresilon.
Rama D is listed as Regulatory Affairs| Women Who Empower Innovator Awardee 2024 | Lean Six Sigma Yellow Belt Certified | HIPAA Certified| Huntington 100 |Ex- IBM'er |Agile Star Awardee at Cresilon.
Rama D is based in Boston, Massachusetts, United States while working with Cresilon.
Rama D has worked for Cresilon, Regintl, Northeastern University, Institute For Experiential Ai At Northeastern University, and Ssi People.
Rama D's colleagues at Cresilon include Caline Fernandes, Kevin Stein, Ignace Vallejo, Eric Gayzler, and Christopher Moore.
You can use AeroLeads to view verified contact signals for Rama D at Cresilon, including work email, phone, and LinkedIn data when available.
Rama D holds Masters, Regulatory Affairs, 3.97/4 from Northeastern University.
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