Madarasab Nadaf

About Madarasab Nadaf

Overall 10+ Years of Experience in Medical Device Domain, worked on class I, IIa, IIb and…

Experience

1. Senior Regulatory Engineer

   L&T Technology Services

   Sep 2021 — Present · Bengaluru, IN

   Preparing Regulatory Strategy Guidelines for Medical Device for class II. Ex: Stryker Orthopaedics, Joint Implants – Bone Plates and Screws. Implement FDA 510(k) submission process to Medical Device Risk-based classification of Medical Devices Identifying the Predicated device and comparing it with current NPD product. Preparing the eSTAR with the help of Technical document details Preparing/updating the Dosier/STED document as per the performance testing reports like Biocompatibility/Risk Assessment/Clinical Data/Labels and IFU. Submitting eSTAR template or eCopy format via the CDRH Portal. Involves design & Development documents, including drawings, design Verification and Validation test Reports of existing products in the market to ensure compliance with applicable standards and against design input documents. Drafting and updating Risk management Plan, Reports & FMEA’s as per ISO 14971. Updating Essential Requirement Checklist (ERC). Collaborating with Subject Matter Expert (SME’s)for each “n” number of standard categories, including but not limited to animal derivatives, biocompatibility (ISO 10993), Sterilization, usability engineering (IEC 62366) for the products across various global sites. Analysing and evaluating the Risk of identified gaps in standard compliance, ensuring comprehensive Risk Assessments are conducted to understand the impact of the gaps on product quality and safety. Responsibility in creating & closure of design control elements like design change control process/plan, design output, design verification, design validation, design transfer, design history file/ design master record and respective design reviews with cross functional teams/stakeholders. Error Flagging for Labelling of the products in all platforms, to facilitate the remediation work under Regulatory Affairs role and implementing necessary changes in Global Data (GUDID) maintained by US FDA.

Education

• Visvesvaraya Technological University

  Bachelor of Engineering - BE

  2012 — 2015