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 time and escalate if there is a lack of support from stakeholdersResponsible for providing regulatory assistance in executing Medium level product optimization projects (Complexity Level L2), work with product certification agencies like UL to update the reports if the proposed product change is critical to the safety performance. Monitor and manage RA project timelines and provide updates to project stakeholders.Assist in interactions with outside experts, partners, and regulatory agencies to understand market access requirements for specific productsOrganize technical meetings with regulatory agencies to understand failures/challenges, if any, and facilitate closure working with the CFT teamOrganize materials from preclinical and clinical studies for review and assist in the review processAssist in peer review of regulatory tasks associated with New Product Development projectParticipates in product reviews and provide a compliance review of each stage gate for both internal product designs or simple OEM branding projectsStay abreast of regulatory procedures and changes in the regulatory climateParticipation and adherence to internal audit requirements per QMS, assist in quality control of regulatory documents and submissionsPerform all job duties in a safe manner and obey all safety policies and proceduresAct in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement, and Innovation)

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 Products.• 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, Southern Africa, Gulf States, Australia, New Zealand).• 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.• Proactively monitor internal and external data sources to identify, investigate and action potentially unsafe products before submission to client.

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 / SASO / UAE / AS / NZS / NMX / BIS - IS standards / US CFR Regulations associated with FDA – EPA – FCC - CPSC / CE marking / ISI Marking.• 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.• Provides a comprehensive research reports based on the required regulatory information.

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.• Assist other departments in answering customer calibration & sales requirements.• Update the calibration manual & other procedures specific to the calibration process.• Control of the calibration measurement uncertainty & internal quality control checks.• Acting on applicable specialist group-related RCA’s (Root Cause Analysis) for CAPA’s (Corrective & Preventive Action) that come out of NCR’s (Non Conformance Report).• Key Co-ordination with Dubai Municipality for up to date revisions & accreditations.• Supervising and conducting technical training to improve qualification of the staff.• Key Clients dealt with: GE, Nestle, Serco Dubai Metro, Linscan, Imdaad, Atlantis Hotel Palm Jumeirah, EMAAR, DAMAC & all other MEP cum Hotel - Hospitalities.• Participation in ADIPEC, Big 5 & Other reputed exhibitions as exhibitor & visitor.

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 Diagram, Picture, Workability, Risk Analysis, Essential Safety Requirements, Test Report Conforming to EN Harmonized Standard, EC Declaration of Conformity, Instruction for Use & Draft Label.• 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.• Documentation & Reporting of Certification Procedures after proper Auditing.• Conducting & verifying Safety Test for Electrical Equipment’s as per IEC 60204-1, IEC 61439-1, IEC 60335-1, IEC 61010-1, IEC 60950-1 & Medical Equipment’s as per IEC 60601-1, IEC 62366-1 from NABL Accredited Laboratories under ISO 17025.• Submitting TCF along with Test Report to European Notified Bodies like Eurocert, Kalitest, Alberk QA Technic, European Inspection and Certification Co., SCA & SZU for CE Approval.• Handling Surveillance Audit for the Certified Products once in a year.• Visual Verification of Welding Related files (WPS, WPQR, PQR, RT, UT, AWS) & Fire Extinguishing Media Tests as per BS EN 1568-3 , BS EN 1568-4 & BS EN 615.

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 Control Systems, Real Time Information Systems and various types of control schemes/principles.• Handled Calibration & Maintenance of various Process Control Instruments (Transmitters, Gauges, Switches, Meters & Valves etc)• Prepared job packs for those jobs that cannot be carried out in a running plant due to operational constraints which include work specifications, man-hours estimation, identification and sourcing of required material, compiling all relevant documents like permit to work, P&ID, schematic drawings, vendor drawings, plot plan etc.

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