AKASH PANMAND
Pune
Summary
Accomplished Senior Engineer at Tata Elxsi with expertise in regulatory compliance and quality management. Successfully transitioned multiple medical device classes with zero non-conformances, enhancing compliance readiness. Proficient in ISO 13485 documentation and skilled in cross-functional collaboration, driving efficiency and accuracy in compliance-critical environments.
Overview
1
1
Certification
7
7
years of professional experience
Work History
Senior Engineer Medical Device Quality & Regulatory
Tata Elxsi
Pune
04.2023 - Current
- Regulatory Compliance & Quality Management:
- Successfully contributed to regulatory transition of multiple medical device classes with zero compliance delays
- Led technical analysis of medical device geometries and specifications for biocompatibility and safety assessments
- Conducted systematic gap assessments to identify and address regulatory issues and compliance gaps before submissions
- Ensured closure of regulatory compliance items ahead of deadlines through effective tracking and follow-up
- Performed root cause analysis on compliance issues and implemented corrective actions to enhance compliance
- Conducted investigations to analyze compliance issues and identify root causes.
- Maintained accuracy in compliance-critical documentation and quality records
- Performed data extraction and analysis on complex technical documentation for regulatory requirements
- Coordinated with cross-functional teams (engineering, vendors, regulatory) to resolve quality issues systematically
- Identified, analyzed, and onboarded critical vendors for contract manufacturing in NPD projects
- Managed vendor compliance documentation and regulatory requirements
- Creation of labeling and labeling specification documents, ECR & ECN in Windchill.
- Developed projects in lofware to manage enterprise labeling and artwork, ensuring integration with Windchill documents.
- Drafting and finalising IFU in vasont component content management system namely Inspire, with publication.
- Developed and maintained consistency in technical terminology and documentation standards
- Improved documentation accuracy by implementing systematic review and tracking processes
- Created standardized documentation templates for consistency across regulatory submissions
Mechanical Engineer Medical Device Compliance
Tata Elxsi
Pune
05.2021 - 04.2023
- Managed comprehensive verification and validation documentation packages for ISO 13485-compliant medical devices
- Conducted gap assessments that identified regulatory issues and compliance shortfalls, enhancing overall compliance readiness
- Coordinated resolution of compliance gaps with engineering and quality teams, ensuring timely alignment with regulatory standards
- Prepared technical documentation and regulatory reports to support compliance initiatives and facilitate regulatory submissions
- Key Achievements:
- Transitioned multiple classes of medical devices with zero regulatory non-conformances
- Reduced compliance issue resolution time by 30% through systematic tracking and management
German Language Specialist (Technical & Regulatory Focus)
Tata Elxsi
Pune
04.2019 - 05.2021
- Translated complex technical and regulatory documents from German to English, ensuring clarity and compliance with industry standards
- Ensured precision in technical terminology across multilingual regulatory documentation, supporting effective communication and compliance
- Developed and maintained specialized terminology databases, enhancing consistency and reliability of medical device and regulatory terminology
- Gained deep understanding of European medical device regulatory requirements and quality standards
- Built comprehensive regulatory terminology database used across multiple projects, improving translation consistency to 99%+
- Earned acknowledgment for exceeding project expectations.
Education
Diploma - Mechanical Engineering
Maharashtra State Board of Technical Education
Pune, India01-2012
Higher Secondary Certificate Examination -
Residential Junior College
Ahmednagar, India01-2009
Skills
- Complaints management and quality assurance
- Regulatory compliance and documentation
- Gap assessment and issue identification
- Complaint investigation and root cause analysis
- Quality data management and documentation
- ISO 13485 and FDA compliance
- Technical and analytical skills
- Data extraction and analysis
- Technical documentation management
- Process documentation and SOP development
- Multilingual Technical Writing
- Cross-functional collaboration
- Attention to detail in compliance environments
- Rapid learning of tools and processes
- Timeline management in quality environments
- Regulatory Strategy Development
- Bilingual Professional (English & German)
- Cross-Functional Collaboration & Stakeholder Management
- Attention to Detail & Accuracy in Compliance-Critical Environments
- Regulatory Process Optimization
- Timeline & Priority Management in Fast-Paced Quality Environments
- Quality Management & Regulatory Systems
- ISO 13485 Compliance & Documentation
- FDA 21 CFR Part 820 (Medical Device QSR)
- Complaint Management Processes & Investigation
- Gap Assessment & Root Cause Analysis
- Regulatory Reporting & Documentation
- Software & Tools (Rapid Learning Capability)
- Quality Management Systems (CMS)
- Windchill, Loftware, Vasont-Inspire
- Technical Documentation (JIRA, MS Office Suite)
- CAD Analysis (SolidWorks - Data Extraction)
- Technical Document Translation
- Database & Information Management
- Data extraction and systematic analysis
- Excel proficiency for trending and reporting
- CMS and PLM system navigation
- Quality data management and organization
- Regulatory compliance
- Medical device labeling
- Windchill documentation
- Vendor compliance
- Technical documentation
Personal Information
- Title: Medical Device Quality | Complaints Management | Regulatory Compliance
- Availability: immediate availability
Certification
- German Language - Goethe-Zertifikat B2, Goethe Institut | 2017 | Pune, India
- Application of Risk Management for Medical Devices According to ISO 14971:2019 Standard Training Program by TÜV SÜD
Timeline
Senior Engineer Medical Device Quality & Regulatory
Tata Elxsi
04.2023 - Current
Mechanical Engineer Medical Device Compliance
Tata Elxsi
05.2021 - 04.2023
German Language Specialist (Technical & Regulatory Focus)
Tata Elxsi
04.2019 - 05.2021
Diploma - Mechanical Engineering
Maharashtra State Board of Technical Education
Higher Secondary Certificate Examination -
Residential Junior College