Himali Goradia

I am an experienced Medical Device Regulatory Affairs and Quality Assurance professional aspiring to diversify my skill sets and continue service in the healthcare industry.

Worked on Class II, and III medical devices.

Summary of Responsibilities

• Design control: User Needs, Design Inputs, Verification, and Validation activities
• Risk Management: FMEAs, Preliminary Hazard Analysis, Risk Management plans 
• Change controls, Labelling Review, Updating Technical documentation, GSPRs, LOAS, Regulatory Plans, and Impact assessment
• Knowledge in filing sections of 510(k) submission, IVDR, Health Canada

Senior Engineer - Quality and Regulatory                                                                                   04/2021 to 04/2022 

Tata Elxsi – Pune, Maharashtra, India 

• Worked on EU MDR and DHF Remediation project for Class Ir, IIa, and III products 
• Identified gaps in DHF files during EU MDD to MDR transition 
• Created Risk documents such as Risk Management plan, Product Characterization (EN ISO 14971 Annex C), Preliminary Hazard Analysis 
• Prepared Regulatory plans, General Safety and Performance Requirements (GSPR) report, and List of Applied Standards, and Usability Engineering report related to IEC 62366-1
• Reviewing labeling and marketing materials for compliance with EU regulations.
• Prepared Summary of Technical Documentation (STED) under respective sections
• Collaborated with UK and France regulatory teams and worked on the GMED submissions and license renewals, Change Control Regulatory Impact assessment, and its implementation on regulatory documents 
• Worked with UK regulatory team in completing International Registration Request (IRR) 
• Developed and maintained the DHF files and technical documentation in accordance with EU regulations
• Worked with cross-functional teams such as clinical, research, and design teams to remediate the respective gaps 
• Tracking progress using the Jira tool

Sr. Development Engineer II                                                                                                         01/2017 to 07/2019 

Zimmer Biomet (Modis E&T, LLC) – Warsaw, Indiana, USA 

• Worked on DHF remediation project for Class I, II, and III implants and instruments 
• Established Zimmer Biomet Legacy Product Design History Files (DHF) in accordance with ISO 13485, ISO 14971, and 21 CFR 820 and ensured all regulatory requirements were met.
• Led team in developing User Needs, Design Input documents for Foot and Ankle systems using Zimmer Biomet Operating procedures and Work instruction in VAULT System
• Gain experience in Regulatory requirements associated with design controls
• Co-ordinated with other teams to conduct gap assessment and identify a budget for verification and validation studies
• Analyzed complaints and post-market surveillance (PMS) reports to identify risk, hazards, and failure modes
• Assisted Quality Engineers in creating Failure Mode Effect Analysis (dFMEA and uFMEA), Hazard Analysis, Risk Management Report, and Overall Risk-Benefit Analysis (ORBA)
• Developed verification and validation testing in reference to the user needs and design inputs generated
• Prepared verification assessment document to justify gaps in existing verification reports
• Led Impact assessment to verify all inputs are satisfied by verification activity, and Validation assessments to validate all the user needs statistically 
• Conducted design review meeting to identify and resolve any issues, dependencies, and risk in any deliverables as well as to track the progress of the project.

Quality Assurance Associate                                                                                                        05/2016 to 01/2017 

Axcellerate Pharma LLC – Piscataway, New Jersey, USA 

• Worked on authoring, reviewing, and approving company policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs) 
• Audited Clean rooms (ISO 5, ISO 7, and ISO 8) and equipment in clean rooms to meet quality attributes required by customers and regulatory agencies 
• Conducted training on Cleanroom gowning procedures, and on SOPs such as good documentation practices (GDP), cleanroom procedures as per the latest SOPs and WIs

Masters in Biomedical Engineering and Biotechnology