Kaviya P

• Performing gap analysis according to EU MDR and US FDA requirements.
• Prepare and review data analysis related to EUA, AMR, ROW service line indicators.
• Participated in regular meetings of various departments and delivery.
• Prepare and compile technical and non-technical documents as per regulatory requirements for client.
• Established planning and implementing new ideas for business growth.

• Hands on experience in EU MDR 2017/745 medical device regulations.
• Reviewer for all deliverables related to chemical characterizations of materials (ISO 10993-18) and providing the Final Inspection Report to the author regarding the observations and ensuring the defect free deliverables.
• Performed gap assessment and remediation activities for Biocompatibility, Extractables & leachables, Animal origin, Part Specifications, Sterilization, etc...
• Developed strong team skills, including communications, teamwork, initiative and managed execution of all project deliverables.
• Interacted with client for projects discussion and supported clients in ensuring the EU regulatory compliance of Class I, Class II medical devices.
• Knowledge on Technical dossier and Clinical evaluation report.

Additional responsibility:

• Configuration Controller- Maintained the folder structure and version controlled for more than 100 peoples in the team.
• Conducting internal process quality (PQA).

Extensive knowledge in developing, monitoring and tracking of projects.

• Maintaining device history file, device master record, device history record (DHF, DMR, DHR).
• Handled around 40 engineers database across few regions and monitored their dailywise task details using CRM Software.
• Having service knowledge in the products such as Incubators, CPAP, Delivery Tables, etc...