Renuka Ramachandran

About Renuka Ramachandran

Highlights of Expertise:• Design Control. AI/ML in Medical device • 21CFR Part 820, ISO 13485• IEC 62304. CSV/CSA• ISO 14971 – Risk Management• HIPAA • ISO 27001 • QMS and ISMS auditor• Design Control management tools: Jira, Mingle, VMWare, bugzilla. Source control: GitHub • Document Management: DOORs, Confluence, SAP, Veeva • Complaints management - eTQ. eTMF - Veeva, Trial Interactive

Experience

1. Director, Software Quality and Regulatory Compliance

   Delfi Diagnostics

   Jan 2022 — Present · Palo Alto, CA, US

   Software design control, AI/ML in medical device, Information security compliance, ISO 27001:2022 Lead auditor, software vendor management, risk based CSV/CSA

Education

• University of California, Santa Cruz

  Bioinformatics

• Sri Ramachandra Medical College and Research Institute

  Bachelor's degree, Pharmaceutical Sciences

Skills

• Hplc
• Cross-Functional Team Leadership
• Iso 14971
• High-Performance Liquid Chromatography (Hplc)
• Design Control
• Gmp
• Computer System Validation
• Verification and Validation (V&V)
• Biotechnology
• Sequencing Instrumentsystem/Software Testing
• Medical Device Validation
• Validation
• Corrective and Preventive Action (Capa)
• Quality Assurance
• Life Sciences
• Chromatography
• Complaint Management
• Iso 13485
• Agile Methodologies
• Medical Devices
• Capa
• U.s. Food and Drug Administration (Fda)
• Iso 27001
• Software Quality Assurance
• Quality System
• Scrum
• 21 Cfr Part 820
• Testing
• Hipaa