Regulatory Affairs Assistant
CurrentWorking on submissions for a wide range of Endoscopy Accessories for East Asian Countries Working on DMF and technical documents for the CDSCO submissionWorking on MDD-MDR Transition
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Hariharan M is listed as Regulatory Affairs Assistant | Medical Devices | US FDA | EUMDR | Health Canada | CDSCO | SFDA | PMDA | MFDS | TFDA | HSA | MDA at Ovesco Endoscopy AG, a company with 32 employees, based in Greater Chennai Area, India, India. AeroLeads shows a matched LinkedIn profile for Hariharan M.
Hariharan M previously worked as Regulatory Affairs Assistant at Ovesco Endoscopy Ag and Technical Project Specialist II at Elexes Medical Consulting Llc. Hariharan M holds Bachelor Of Engineering - Be, Biomedical/Medical Engineering, Cgpa 7.2/10 from Anna University.
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With a foundation in biomedical engineering from Dhanalakshmi Srinivasan Institute of Research and Technology (Affiliated by Anna University) I now advance medical device approval processes as a Regulatory Affairs Assistant at Ovesco Endoscopy AG. Our team focuses on the meticulous preparation of submissions across East Asian countries. Harnessing my competencies in Visio and Microsoft Excel, I facilitate the transition to the MDR from MDD and ensure the integrity of technical documentation for CDSCO submissions. My commitment lies in upholding the highest standards of regulatory compliance, contributing to the delivery of safe, effective endoscopy accessories to the healthcare industry.
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Chennai, Tamil Nadu, India
Working on submissions for a wide range of Endoscopy Accessories for East Asian Countries Working on DMF and technical documents for the CDSCO submissionWorking on MDD-MDR Transition
Bengaluru, Karnataka, India
Overhauling the project deliverables Internal reviews of technical documents and internal technical repository documentsAssist in the preparation of technical presentations/ meetings with managersCoordination with internal stakeholders to ensure the quality of deliverables
Bengaluru, Karnataka, India
Regulatory submission will also include Preparation of requirement checklists and all the associated evidences right from Device specification, Requirements to Risk analysis, Verification and Validation.Preparation of IFU’s, Operation Notes from third partyand verifying it for timely release for new updates.Expertise in Regulatory Standards of Country.
Bengaluru, Karnataka, India
Have taken to be a part of the Critical breakdown calls independently from ICU to OTManaged Operation Theater breakdown calls effectively. Overall Insight of all Surgical procedures in OTIdentify elements and requirements for improvement of maintenance posture for medical devicesAssisted in various surgical procedures during unexpected critical equipment.
Other employees you can reach at ovesco.com. View company contacts for 32 employees →
Daniel Márquez Caraveo
Colleague at Ovesco Endoscopy Ag
Tübingen, Baden-Württemberg, Germany, Germany
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Oscar Edmundo Conde Grande
Colleague at Ovesco Endoscopy Ag
Lustnau, Baden-Württemberg, Germany, Germany
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Anette Bort
Colleague at Ovesco Endoscopy Ag
Tübingen, Baden-Württemberg, Germany, Germany
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JL
Jorinde Loeser
Colleague at Ovesco Endoscopy Ag
Greater Tubingen Area, Germany
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Louis Straub
Colleague at Ovesco Endoscopy Ag
Tübingen, Baden-Württemberg, Germany, Germany
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HT
Hoda Tajrobehkar
Colleague at Ovesco Endoscopy Ag
Stuttgart Region, Germany
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Essie Clayton
Colleague at Ovesco Endoscopy Ag
Greater Houston, United States
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NK
Nataliia Kazora
Colleague at Ovesco Endoscopy Ag
Nurtingen, Baden-Württemberg, Germany, Germany
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SG
Sara Gebhardt
Colleague at Ovesco Endoscopy Ag
Germany, Germany
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AK
Angelina Kondratev
Colleague at Ovesco Endoscopy Ag
Metzingen, Baden-Württemberg, Germany, Germany
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Quick answers generated from the profile data available on this page.
Hariharan M works for Ovesco Endoscopy AG.
Hariharan M is listed as Regulatory Affairs Assistant | Medical Devices | US FDA | EUMDR | Health Canada | CDSCO | SFDA | PMDA | MFDS | TFDA | HSA | MDA at Ovesco Endoscopy AG.
Hariharan M is based in Greater Chennai Area, India, India while working with Ovesco Endoscopy AG.
Hariharan M has worked for Ovesco Endoscopy Ag, Elexes Medical Consulting Llc, and Manipal Hospitals.
Hariharan M's colleagues at Ovesco Endoscopy AG include Daniel Márquez Caraveo, Oscar Edmundo Conde Grande, Anette Bort, Jorinde Loeser, and Louis Straub.
You can use AeroLeads to view verified contact signals for Hariharan M at Ovesco Endoscopy AG, including work email, phone, and LinkedIn data when available.
Hariharan M holds Bachelor Of Engineering - Be, Biomedical/Medical Engineering, Cgpa 7.2/10 from Anna University.
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