Premkumar Sivaraman
FC Associate at Amazon
- Bangalore, Karnataka, India
- premkumarsivaraman19@gmail.com
- +44 7769 055994
I am an experienced professional with a strong background in Post Market Surveillance (PMS) document preparation and EU-MDR Regulatory Affairs. My expertise encompasses a comprehensive understanding of ISO 13485, EU-MDR, and FDA regulations, allowing me to ensure compliance and regulatory adherence in all aspects of my work.
Experience
FC Associate
Responsibilities:
- Efficiently managed outbound warehouse operations, with a primary focus on shipping products accurately and timely.
- Collaborated proactively with a dedicated team to ensure the punctual completion of daily tasks, aligning with operational objectives and meeting customer requirements.
- Maintained an unwavering commitment to workplace safety, consistently adhering to established protocols to mitigate accidents and cultivate a secure working environment.
Impact:
- Facilitated strong teamwork and reliability, playing a pivotal role in consistently meeting and exceeding production targets, thus guaranteeing the timely fulfilment of customer orders.
- Actively engaged in continuous learning and skill enhancement, strengthening personal effectiveness and adaptability to effectively respond to the ever-changing demands of the warehouse environment.
Medical Writer
Responsibilities:
- Prepared and reviewed Post Market Surveillance (PMS) documents, including PMS plans, PMS reports, and Periodic Safety Update Reports(PSUR) to ensure compliance with regulatory requirements.
- Maintained a strong focus on adherence to EU-MDR, ISO 13485, and FDA regulations, contributing to the company's commitment to regulatory compliance.
- Collaborated with cross-functional teams to establish and maintain effective PMS processes and Standard Operating Procedures (SOPs), fostering a culture of regulatory excellence.
- Analyzed complaint data to identify trends and provided valuable insights for complaint reduction and product performance improvement initiatives.
- Collaborated effectively with all team members to ensure the timely submission of PMS reports.
Impact:
- Ensured the accurate and timely completion of PMS documents, resulting in a 98% compliance rate with regulatory standards and reducing the risk of non-compliance.
- Contributed to a 15% improvement in the efficiency of the PMS process through the implementation of streamlined procedures and SOPs.
Verification Expert (Intern)
Responsibilities:
- Conducted thorough KYC (know your customer) verification for customer ID's, ensuring the accuracy and completeness of customer information.
- Implemented established verification procedures and guidelines to maintain compliance and data integrity.
- Collaborated effectively with team members to consistently meet and exceed daily verification targets.
Impact:
- Achieved a 99% accuracy rate in customer information verification, reducing the risk of fraudulent activities and improving the
overall quality of data.
- Helped streamline the verification process, resulting in a 15% increase in daily verification productivity.
- Contributed to maintaining a high level of customer satisfaction by ensuring accurate and up-to- date information, which was reflected in a 5% reduction in customer complaints related to verification processes.
Projects
missing mri pulse sequence synthesis using multi-modal generative adversarial network (2021)
- medical device
- regulatory affair
- team management
- trend analysis
- communication
- quality management system
- quality assurence
- kyc process
- document verification
- The traditional method in hospitals is to segment the medical image under consideration, manually and this depends on how well the physician can perceive the image under consideration to get the required region extracted out, which is made difficult because of minute variations and resemblance between the original and affected biological part in the image.
- Mention measurable impact or results you helped deliver. Focus on the outcome of tasks. Example: Modified customer service support system to reduce complaints by 10%.
Financial Analysis of Medical Device Development and Commercialization: A Case Study Approach
- The current research is completely focused on the financial analysis of medical device development and
its commercialisation. The study also focuses on the formulation of cost-reduction strategies for healthcare organizations engaged in the manufacturing of medical devices. Application of automation and update is highly effective in order to minimize costs related to medical device development as it reduces 30% of operational costs of Healthcare organizations including Abbott Laboratories and Philips Laboratories
- Mention measurable impact or results you helped deliver. Focus on the outcome of tasks. Example: Modified customer service support system to reduce complaints by 10%.
Awards
Customer Appreciation Award
Received the Customer Appreciation Award from Tata Elxsi Pvt Ltd in April 2022 for outstanding performance in delivering client projects within deadlines, demonstrating a commitment to customer- focused excellence.