M.ELAKKIYA MURUGESAN

• Working for the team in various OSCAR projects in India.Involved in supporting and enabling the team members toward achieving their goals.
• Managed to complete the auditing of warehouse for their ready accommodation of Medical devices.
• Oversaw all the regulatory standards are correctly maintained according to the Indian Medical device rule and warehouse act.
• Coordinated with cross-functional teams to ensure successful project implementation.
• Maintained the records for Proposed change in an existing device . where it needs to be closely monitored and timely report has to be delivered to the Government authority.
• Product compliance handling is also been supported by me to take the customer compliance , feedback and also monitor for any adverse event or serious adverse event reported.
• Manage the smooth customer friendly relationship and support them with the investigation report of their further process.
• Regularly monitor the ASEAN Regulatory intelligence report and maintain the Regulatory trigger , where all the country reports are listed fro the periodic maintainence.

· The Central Drugs Standard Control Organization (CDSCO ) is the regulatory body of India that provides Clearances of Drugs, Medical Devices,IVDs and cosmetics. Our team works on getting Registration Certification for drugs and getting imported to INDIA

· We work getting registration for various medical devices and pharmaceutical drugs

· Work and maintain the special notes for procedures that need to be carried while preparing the documentation and maintain and ensure the work goes in flow within the team.

· Prepare the blogs related to the work and publish in our company website to get more clients.

· Maintain the follow up with client from various countries and ensure their work status.

· Ensure the Documentation is submitted without error and also follow up with the CDSCO.

· In case of any correction that is been indicated by CDSCO must engage with team to resubmit the document and ensure to get Registration Certificate.

· Making the team to understand about all standards EU/CA/WHO/US regulations & guidelines allowing appropriate review and compilation of data to appropriate standards & requirements.

· Follow up with clients in renewals, assessment of change controls and associated technical dossiers.

• Extraction of formula from various research papers and giving a competence report with the help of subject matter expertise (SME) in the field of Bio Medical, Hospital Managements and pharmaceutical, Managing with the team to produce and extract report what the client looks and helps them to give a clear cut idea of the project, Help them with presentation to get the overview of the project with a team of 6 members

· Creating contact database and reports

· Cold calling and email outreach for generating leads

· Identifying prospects and digging for opportunities

· Formulating sales strategies for long term revenue growth and target.

· Conducting technical seminars regarding the product understandings to the customer

· Prepare quotations and send offers for the customer enquiries and extend the support

further in service side of the equipment we supply

· Monitor the tender activities and prepare offer for the following tenders.

· Managing the export and import activities and packaging activities as a coordinator