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.