Amith Padmanabhan Email & Phone Number

Hyderabad, Telangana, India

Hyderabad, Telangana, India

Responsible for execution of Class I & II medical device product registrations in various countries/geographies interfacing with the cross-functional teams (Engineering, Operations, Quality, Sales Registration Agents )Reviews and organizes dossiers and submission packages for agencies communicate renewal obligations to the cross-functional team ahead of.

Pune, Maharashtra

• Research on country regulations and product standards on Electrical and Electronics, Chemical, Furniture, Home - Garden, Textiles, Cosmetic, Juvenile Products, Medical Devices, Automobiles, Toys - Games & General.
• Regulatory Product Compliance Management for 14 Regions (Central Asia, South-East Asia, Eastern Asia, Western Asia, Southern Asia, European Union, South America, North America, Central America, Northern Africa.
• Direct client dealing with respect to product/regulatory reviews & suggestions.
• Client Dealt with: UL (Underwriter Laboratory)
• Project Dealt for: Amazon, Adeo
• Served as designated specialist within the Compliance Team, acting as a point of contact and process expert for other colleagues.

Hyderabad Area, India

• Provide global market access services information to clients (manufacturing, testing, labeling, packaging, import-export & certification).
• Provides quality and technically-based opinion on product standards and product classification and certification.
• Knowledge of EU directives ( LVD, MD, MDR, IVDR, RED, EMC, RoHS, WEEE, REACH ) / Prop 65 / IEC / EN / ISO / GB / SANS / GOST / DSTU / ABNT / IRAM / BS / TS / JIS / KS / DIN / NF / UL / ANSI / ASTM / CSA / CGSB / GSO /.
• Experience in regulatory research and analysis.
• Global compliance/International compliance/Regulatory compliance.
• Coordinate and implement all areas of the Product Safety Regulatory Assistance in collaboration with the Compliance Team.

Dubai

• Dual role as Quality Manager & Instrumentation Engineer for Calibration Lab & Instrumentation Product Sales Service (MEP, Oil & Gas, HVAC, Process Industries).
• Quality & Sales Activities Dealt for: Pressure, Temperature, Level, Flow, Mass, Electrical, Linear, Torque Wrench & Portable Measuring Instruments.
• Preparation & Coordination with ISO 9001 (QUALITY MANAGEMENT SYSTEM) & ISO 17025 (CALIBRATION/TESTING LAB REQUIREMENTS) documents, personal & team.
• Developing Inspection Test Plans (ITP) for all categories of equipment of discipline area.
• Conduct field execution QA/QC audits ensuring compliance against company calibration plans, procedures & develop reports/recommendations to highlight/close identified improvement opportunities.
• Provide support to SAT/FAT (Site/Factory Acceptance Test) activities as required, ensuring test plans meet company requirements and accept test results.

Pune, Maharashtra, India

• Responsible for Project coordination from the start to end for CE, ISO, ATEX, RoHS Inspection & Certifications.
• Knowledge on European Directives (LVD, MD, PED, CPR, EMC, MDD, AIMD, IVDD, ATEX, Reach, ROHS) and European Standards (EN, IEC, ISO, BS).
• Expertise in ISO 9001(QMS), ISO 17025(Testing & Calibration) & Basics in ISO 14001(EMS), 18001(OHSAS) & 13485(MD QMS).
• Active participation in development of Technical Construction File (TCF) for clients which comprises of Company Profile, License Details, ISO certificate, Technical Description, Drawing, Design Calculation, Circuit.
• Assuring product safety through Inspection of Electrical Installations including materials, methods, specifications & hazardous area identification.
• Understands international (IEEE, IEC, AGA, ISA, NEC/NFPA, NEMA etc.) codes and standards relating to instrumentation/electrical.

Cochin Area, India

• Production incharge duty to handle Zinc Production in Binani Zinc Limited factory.
• Installation, maintenance and fault finding of electronics and pneumatic instruments and control system.
• Exposure in Commissioning, Loop checking, P&ID Diagrams, Loop & Shop Drawings.
• Monitors SCADA and controls on-site PLC/Instrument work undertaken.
• Carries out the more complex maintenance and repair activities of the section, such as checking and replacing complicated interlocks and shutdown equipment components.
• Exposure under Lead Engineers on field instrumentation (transmitters, control/SD valves, analyzers, F&G detectors) DCS, ESD/F&G Systems, Package PLCs, Anti Surge Control Systems, Metering Systems, Turbine/Compressor.

Master Of Technology (Mtech), Quality Management, 7.85 Cgpa

Activities and Societies: Total Quality Management, Reliability, Operations Management GRADUATED on MARCH 2019

Bachelor Of Technology (Btech), Applied Electronics And Instrumentation, 74.13

Activities and Societies: Member of Instrumentation Society of India Technical Fest & Science Exhibition Coordinating