Business Systems Analyst in Bangalore, भारत

Business Systems Analyst position responsible for implementing system and process improvements in Document Control at a medical device company. The role involves managing change orders, collaborating across departments, and ensuring regulatory compliance with PLM systems and document control standards.

Responsibilities

• Execute PLM system and document control process improvements using Agile methodologies
• Process change orders accurately and audit documentation for compliance with regulatory requirements
• Represent Document Control in project requirements definition and participate in cross-functional project teams
• Create test scripts, execute user acceptance testing, and coordinate with CSV groups on regulatory compliance
• Update procedures, resolve complex tickets, and provide clear communication to internal stakeholders

Requirements

• 6-10 years work experience in regulatory or quality organizations in medical device companies
• Knowledge of PLM systems (Agile preferred) including functional and technical aspects
• Understanding of change control principles for document control and IT systems
• Experience with cross-functional project teams and process improvement initiatives
• Proficiency in Microsoft Office products (Word, Excel, Visio)
• Strong analytical thinking, problem-solving, and attention to detail
• University degree; Quality Systems Regulations, ISO, Project Management, and Validation training