KOGAAN ANBALAGAN

• Manage, maintain, and track customer complaints for class III products using the quality system database in compliance with site procedures and regulatory agencies, specifically 21 CFR part 820 and 21 CFR part 803 complaint files and medical device reporting (MDR).
• Interface with healthcare professionals at all levels (such as physicians, nurses, biomedical technicians, and purchasing agents) to document, investigate, and correct field-related problems.
• Analyze and resolve customer technical and clinical questions regarding company products.
• Meticulously evaluate each complaint file via Epiq database, adhering to strict regulatory compliance, specifically 21 CFR part 820 and 21 CFR part 803.
• Communicate customers' concerns and complaints to individuals managing databases and analyze the data to identify trends, needs for product and service enhancements, and communicate the findings with relevant individuals such as R&D engineers and business unit managers.
• Participate in product improvement teams, field failure analysis, and other analytical responsibilities to improve products and address regulatory issues.
• Act as a subject matter expert (Coding SME) to regulate the usage of IMDRF terminologies for categorization for MDR reporting.
• Escalate unusual product performance issues judiciously and work closely with engineering to resolve customer complaints.
• Independently triage and investigate several hundred complaints a month from around the world on Abbott CRM products.
• Provide support to the legal department regarding product performance.
• Have strong multitasking skills to perform product complaint documentation, investigation, customer responses, and consulting activities on company products, and author correspondence to customers addressing complaint investigations.

·Lead the product team in managing overall project, research and development efforts, and coordinating manufacturing for new and emerging products in the urology product range.
• Provide training to subordinates and other departments to ensure compliance with the quality management system and internal processes for the product range and standard operating procedures (SOP) for the product team.
• Develop, implement, and validate product inspections to ensure product quality and performance.
• Provide technical and quality engineering input within operations and quality. Responsible for creating and maintaining all paperwork associated with product development, such as product realization, medical device files, and product specifications based on ISO 13485 and ISO 9001 standards.
• Lead and supervise subordinates, including designers and other marketing staff, in their daily work.
• Provide technical expertise and training to other departments in support of product development, particularly the Sourcing and Logistics department.
• Establish product specifications and barcode requirements for the manufacturer's implementation.
• Coordinate and review packaging artwork from designers to ensure it meets product requirements and complies with medical device regulations.
• Lead creative development and provide marketing support and training materials for the distributor’s sales forces.

• Coordinate and develop marketing brochures, literature, material safety data sheets, and product specifications.
• Work with technical and consulting teams to deliver solutions that meet customer needs.
• Strategize, propose, and negotiate business propositions with prospects and business partners.
  - Coordinate corporate events, training, workshops, and exhibitions, managing event aspects, budgetary control, and post-event appraisals.
  - Serve as a member of the Good Manufacturing Practices & Product Safety team.
  - Revise documents for licensing applications and product registrations with the Pharmaceutical Control Bureau of Malaysia (BPFK).
  - Stay updated on current regulations regarding drug and device product, particularly on pharmaceutical product regulatory matters.
  - Assist in GMP documentation, leveraging excellent verbal and written communication skills, and strong technical writing skills for GMP documentation.
• Prepare training and qualification modules, schedule and organize regular in-house technical training sessions.
• Ensure paperwork adheres to Standard Operating Procedures and complies with relevant international standards and guidelines.
• Research new ingredients and identify alternative qualified ingredients for new product development.
• Generate test plans for finished premixes to establish minimum, target, and maximum specifications, particularly for essential oil products and biofertilizers.

• Assist in the preparation for study initiations and attend all related meetings.
• Perform environmental monitoring of the clean rooms under ISO specifications.
• Perform microbial characterization, including gram stain, catalase, oxidase, and coagulase tests.
• Conduct aseptic testing, microbial monitoring, gram staining, sub-culturing, and other related tests.
• Evaluate laboratory practices for continuous operational excellence improvement.
• Plan and perform multiple complex routine and non-routine methods and procedures on a variety of assays.
• Plan and initiate investigator meetings and manage the processing of travel claims.
• Teach laboratory skills to intern students, focusing on Molecular Basis related to RNA studies.
• Conduct transcriptome analysis and RNA extraction from Salmonella biofilm, as well as non-coding RNA analysis related to aging studies.

• Extraction of RNA from macrophage cells
• Quality control of RNA before sending for Next-Generation Sequencing
• Beginner-level bioinformatic analysis
• Analysis of biofilm formation in various Salmonella species
• Management of inventory for chemicals, reagents, and consumables
• Assistance in preparing for study initiations and attendance at all related meetings