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Dharashri Dhanasekaran Email & Phone Number

Regulatory Affairs Associate for Medical Devices| ISO 13485 Internal Auditor at Medical Developments International (MDI)
Location: Melbourne, Victoria, Australia 6 work roles 2 schools
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Role
Regulatory Affairs Associate for Medical Devices| ISO 13485 Internal Auditor
Location
Melbourne, Victoria, Australia
Company size

Who is Dharashri Dhanasekaran? Overview

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Dharashri Dhanasekaran is listed as Regulatory Affairs Associate for Medical Devices| ISO 13485 Internal Auditor at Medical Developments International (MDI), a company with 53 employees, based in Melbourne, Victoria, Australia. AeroLeads shows a matched LinkedIn profile for Dharashri Dhanasekaran.

Dharashri Dhanasekaran previously worked as Regulatory Affairs Associate at Medical Developments International (Mdi) and Regulatory Analyst at Hcl Technologies. Dharashri Dhanasekaran holds Bachelor Of Engineering, Biomedical/Medical Engineering, First Class from Anna University Chennai.

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Medical Developments International (MDI)

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Profile bio

About Dharashri Dhanasekaran

Biomedical Engineer holding a Bachelor's degree and have 5 years of experience working with medical devices. I am passionate about innovation and excellence, and always strive to contribute to the development of life-saving technologies. I am an adept communicator who is skilled at bridging teams for project success. Furthermore, I have strong problem-solving skills and can navigate complexities with resilience. I am committed to advancing healthcare and have unwavering determination to achieve my goals. I possess knowledge of the requirements for ISO 13485, EU-MDR 745/2017, and 21CFR 820. Additionally, I am a certified internal auditor for ISO 13485-Quality Management System for Medical Devices.

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Medical Developments International (MDI)
Medical Developments International (Mdi)
Regulatory Affairs Associate for Medical Devices| ISO 13485 Internal Auditor
melbourne, victoria, australia
Website
Employees
53
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6 roles

Dharashri Dhanasekaran work experience

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Regulatory Analyst

Chennai, Tamil Nadu, India

Supported on EU MDR submission for Class IIa, Class IIb.SoTA analysisTechnical documentation supportRegulatory plan for 510k process

Jul 2021 - Aug 2023

Associate Consultant-Regulatory Affairs(Medical Devices)

Chennai, Tamil Nadu, India

Oct 2020 - Jun 2021

Regulatory Analyst-Trainee(Qara)

Chennai, Tamil Nadu, India

  • Supports procedures, processes and documentation for maintaining compliance to the Quality Management System, ISO 13485 and other applicable requirements
  • Gap Analysis, of product specific documents to verify compliance to regulatory requirements and technical standards
  • Assists and supports clients in ensuring regulatory compliance and performs other tasks as assigned
  • Interpret regulatory documents and interfaces with stakeholders for approval of changes
  • Preparation of multiple tools, templates in for smooth execution of regulatory projects e. g. 21CFR820, MHLW Ord. 169, EU-MDR etc.
Dec 2019 - Sep 2020

Quality Controller

Chennai Area, India

  • Quality checking of ENT Equipment based on approved procedures
  • Monitoring of performance in every process and focus on the product improvement
  • Coordinating Service personnel and assisting services of ENT equipment
  • Preparation of Product Documentation based on ISO 13485
  • Providing active technical support.
Jun 2019 - Dec 2019

Quality Control Engineer

Kanna Engineering ( Associated With Serwell Medi Equips)

Chennai, Tamil Nadu

  • Quality analysis of ENT materials and final products
  • Supports the evaluation of Advertising and Promotional material for compliance
May 2018 - Jun 2019
Team & coworkers

Colleagues at Medical Developments International (MDI)

Other employees you can reach at medicaldev.com. View company contacts for 53 employees →

2 education records

Dharashri Dhanasekaran education

Bachelor Of Engineering, Biomedical/Medical Engineering, First Class

Activities and Societies: Volleyball player,Table tennis

Student, Group-2(Bio-Maths)

Sahaya Matha Matriculation High.Sec School
FAQ

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Quick answers generated from the profile data available on this page.

What company does Dharashri Dhanasekaran work for?

Dharashri Dhanasekaran works for Medical Developments International (MDI).

What is Dharashri Dhanasekaran's role at Medical Developments International (MDI)?

Dharashri Dhanasekaran is listed as Regulatory Affairs Associate for Medical Devices| ISO 13485 Internal Auditor at Medical Developments International (MDI).

Where is Dharashri Dhanasekaran based?

Dharashri Dhanasekaran is based in Melbourne, Victoria, Australia while working with Medical Developments International (MDI).

What companies has Dharashri Dhanasekaran worked for?

Dharashri Dhanasekaran has worked for Medical Developments International (Mdi), Hcl Technologies, Ilensys T, Ilensys Technologies Pvt Ltd, and Serwell Medi-Equip Private Limited.

Who are Dharashri Dhanasekaran's colleagues at Medical Developments International (MDI)?

Dharashri Dhanasekaran's colleagues at Medical Developments International (MDI) include Clarisse Lhospitalier, Nadira Magad, Maciej Grabowski, Ketul Patel, and Sabrina Pieris.

How can I contact Dharashri Dhanasekaran?

You can use AeroLeads to view verified contact signals for Dharashri Dhanasekaran at Medical Developments International (MDI), including work email, phone, and LinkedIn data when available.

What schools did Dharashri Dhanasekaran attend?

Dharashri Dhanasekaran holds Bachelor Of Engineering, Biomedical/Medical Engineering, First Class from Anna University Chennai.

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