DESIGNATION/ TITLE: Assistant Lead- Validation
ABOUT THE ROLE
Will be supporting in usability engineering, Clinical evaluation plans, risk management activities and post- market surveillance documents.
DEPARTMENT: Quality Assurance & Regulatory Affairs
REPORTING TO: Vice President – Quality Assurance and Regulatory Affairs.
JOB LOCATION: Bangalore
TECHNICAL COMPETENCIES
• Strong statistically and IT skills.
• Attention to detail.
• Analytical thinking.
• Well Organized and time management.
• Excellent coordination
• Focus on task objectives
BEHAVIORAL COMPETENCIES
• Excellent verbal and written communication skills.
• Excellent interpersonal skills.
• Thorough understanding of industry standards and regulatory guidelines.
KEY RESPONSIBILITIES
• Preparing User Requirements/ Usability specifications and Design Inputs, Firmware Requirement specifications & Software Requirement Specifications.
• Preparing Design Review Document.
• Preparing Instructions for Use and a Quick start guide.
• Support with inputs in preparing Clinical Evaluation Plans, Clinical Evaluation Reports, and Clinical Validation reports.
• Conducting Usability Studies and Preparing Usability Specification Documents and Usability Validation Reports.
• Risk management activities
• Supporting Post-market surveillance documents.