Nagarajesh Gorlamandala, Phd Email & Phone Number

Norwest, Nsw, Au

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Accomplishments>Regulatory and Quality deliverables were delivered within 3 months of estimated budgets.>Created value for 5 clients with Regulatory and Quality deliverables in span of 11 months.>Handled gamut of technologies who intend to access 6 markets and delivered value within the timelines.-Developed Regulatory strategies and regulatory plans for novel med tech devices who intend to access US, AU and EU markets.-Experienced and well-versed with regulatory pathways to access US, EU and AU markets.-Co-ordinated with multi-disciplinary cross functional teams during the design and development of medical devices and offered regulatory, quality insights.-Helped start-ups, Academic research groups in mapping out the regulatory hurdles early in the developmental cycle of low-moderate risk and device-led combination devices.-As a Quality and Regulatory Lead across multiple projects, critically reviewed, assessed the impact of regulatory changes and helped designers in building design history files and technical file documentations.-Assisted directors of the business unit in assessing the client's novel technology in the regulatory and quality function.-Understands the regulatory timelines and budgets required. Helped project and product leads in estimation of regulatory and quality budgets.-Established documentation requirements for regulatory submissions with product development teams.-Documented components of technical files during the developmental process of medical devices.-Offered assistance and feedback to improvise the quality systems and procedures of the organisation.-Trained fellow colleagues, peers on regulatory deliverables and critical procedures of the regulatory submission.

Bengaluru, Karnataka, India

• Responsible to determine the reporting and safety decisions for adverse events and device malfunctions for laboratory diagnostic (IVD) portfolio of Siemens.• Reviewed the compliance of devices towards regulations of US FDA CFR 820, EU MDR, EU IVDR, TGA Act in the post market surveillance phase of the lifecycle.• Submitted Adverse events and device malfunction reports to regulatory agencies across the globe.• Worked collaboratively with overseas teams to determine the reporting decisions in timely manner.

• Implemented ISO 13485:2016 standard for the IVD class A device to access European markets.• Facilitated training sessions for the manufacturer to gain expertise in ISO 13485 standard.• Risk mitigation strategies were designed for the device in compliance with ISO 14971:2019 standard.• Standard operational procedures, work instructions and Technical files were drafted for the device manufacturer.

Canberra, Australian Capital Territory, Australia

• Worked as medical device investigator in the Medical Devices Surveillance Branch of TGA focused on all classes of in vitro diagnostic (IVD) kits, Class IIa and I device investigations and Triaging of user and sponsor reports.• Responsible for conducting comprehensive post market reviews of IVD devices.• Liaised with multiple branches of TGA to resolve the complicated investigations.• Engaged effectively with internal and external stakeholders to manage the complex issues arising during the lifecycle of a device.• Reviewed compliance to the standards (ISO 13485, 14971) and quality management systems of the sponsors during the device investigations.• Implemented risk management approach to support regulatory decisions such as Proposal to cancel, Suspend or Cancellation of devices from the market.• Recall actions, Safety Alerts were initiated as part of the Post market surveillance of medical devices for non-compliance with MDR.• Offered timely, quality and accurate advice on issues related to medical device regulation and interpreted the legislation applicable to medical devices.

Sydney, Australia

• Worked with clinical study teams and hospital site staff to facilitate daily trial activities and ensure compliance with research protocols• Managed quality assurance, Trial databases with strong emphasis on detail and project outcomes• Maintained compliance with regulatory framework covering patient care and clinical trial operations • Liaised with Clinical Leads and Project Managers to resolve site audit findings, improve operations and provide exceptional customer service• Proactively engaged in continuous learning of drug development pipeline• Multiple studies across four different phases of clinical development time lines were effectively met while prioritizing compliance and patient safety

Sydney, Australia

* Lead the Pre clinical developmental research project in collaboration with pharmaceutical company.* Simplified and Innovated the methodologies which resulted in filing of a patent by the team.* Communicated the findings to peer reviewed journals.

Unsw, Sydney

Facilitated the students with lab techniques and enhanced their understanding of fundamentals in Biology. Furthermore the role also included assessing a group of 15 students based on their individual and group work by marking their progress tests, individual literature review reports and group practical reports.

Sydney, Australia

Sydney, Australia

Investigation of TRPC ion channels in ischemic brain injury can provide an opportunity to confer novel neuro protective strategies to tackle brain stroke related disorders. Gamut of techniques are used to address this question.- Recording extracellular brain activity from brain slices, - Labelling of proteins through Immuno histochemistry.- Photothrombotic ischemic injury in vivo model..... I have presented my work at International, domestic conferences and inter departmental seminars.

Experimental design and execution of behavioural paradigms, evaluated effects of ageing on somatosensory system.

Kushalnagar, Mysore, India.

Gene Cloning and Bacterial Assays Under the guidance of Dr.H.V.Batra.Genomic DNA isolation & Plasmid DNA isolationQuantification of antigen using ELISA. PCR & Outerchlony double diffusion Radial immunodiffusion & Immuno electrophoresis

Doctor Of Philosophy - Phd, Physiology And Pharmacology

Masters In Sciences, Life Sciences

Activities and Societies: Grama seva, Dramatics and sports

Bachelors In Sciences, Life Sciences

Activities and Societies: Self reliance departments, grama seva