Job Description

: 1) Responsible for execution of general-purpose product registrations in various countries/geographies interfacing with the cross-functional teams(Engineering, Operations, Quality, Sales & Registration Agents ) 2) Assists in the pr

: 1) Responsible for execution of general-purpose product registrations in various countries/geographies interfacing with the cross-functional teams(Engineering, Operations, Quality, Sales & Registration Agents ) 2) Assists in the preparation of dossiers and submission packages for agencies, maintenance of documents and records of registered products, and renewal of the same interfacing with CFT 3) Responsible for providing regulatory assistance in executing simple product optimization projects (Complexity Level L1 & L2 Lite), work with product certification agencies like UL to update the reports if the proposed product change is critical to the safety performance. Monitor and report RA project timelines to the project stakeholders. 4) Assist in preparing for technical meetings with regulatory agencies 5) Organize materials for preclinical review & clinical studies of Medical devices 6) Assist in completing regulatory tasks associated with New Product Development project 7) Participates in product review meetings and understand stage gate requirements for both internal product designs or simple OEM branding projects 8) Participation and adherence to internal audit requirements per QMS (Quality Management System 9) Perform all job duties in a safe manner and obey all safety policies and procedures 10) Act in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement, and Innovation) 11) Perform all job duties within ISO standards, stay abreast of regulatory procedures or statutory requirements.