Rohit Baban Parkale

• Serving as Global Subject Matter Expert (SME) for Medical Device, BCMS Products and Third-Party Lead Auditor for ISO 13485, covering both low- and high-complexity medical devices.
• Successfully completed 50+ days of audit, 800+ technical file report reviews, consistently achieving a turnaround time (TAT) performance greater than 95%.
• Performed technical reviews in accordance with ISO 13485, MDR, ISO/IEC 17021, IAF MD9. Evaluating ISO 13485 reports and related documentation.
• Planned, conducted, and reported ISO 13485 audits in alignment with applicable scheme-specific and regulatory requirements.
• Drove internal quality improvement initiatives through new process development, system gap assessments, and corrective remediation activities, enhancing compliance and operational effectiveness.
• Monitored and analyzed performance metrics, proactively identifying potential accreditation risks and driving preventive actions across teams.
• Delivered training and technical guidance on accreditation requirements and international standards, including ISO 14971, EU-MDR 2017/745, US FDA 510(k), IEC 62304, and IAF MD 09, improving staff competency and compliance.
• Delivered training and technical guidance to staff on accreditation requirements and international standards, including ISO 14971, EU-MDR 2017/745, US FDA 510(k), IEC 62304, and IAF MD 09.
• Interpreted regulatory requirements and standards to support accurate audit and assessment decisions.
• Mentored junior team members, contributing to their professional growth and development.

• Provided quality and regulatory support to medical device development and regulatory projects, including New Product Development (NPDs) related to active and non-active devices) and software-based projects.
• Led and reviewed medical device risk management activities in compliance with ISO 14971:2019 and ISO/TR 24971:2020, ensuring effective identification, evaluation, and mitigation of product risks.
• Reviewed Design History File (DHF) documentation and conducted internal audits for compliance with ISO 13485 and ISO 27001, ensuring adherence to quality standards.
• Led quality improvement initiatives, developing new QMS processes and conducting system gap assessments and remediation activities, resulting in recognized enhancements to risk management processes.
• Tracked project metrics, customer satisfaction, and overall project health, identifying quality risks and implementing preventive actions across teams.
• Delivered training and awareness sessions on regulatory requirements and standards, including EU MDR, ISO 14971, and ISO 13485:2016.
• Reviewed software-based medical device design documentation in accordance with IEC 62366, IEC 62304:2006/2015 lifecycle requirements.
• Acted as a Safety Officer and participated in the organizational Safety Committee to implement and maintain the company's safety policies and practices.
• Reviewed specifications and test cases to improve accuracy, completeness, and compliance.
• Improved verification workflows through root cause analysis and corrective action tracking.

• Performed third-party accreditation and certification audits for medical device organizations under NABCB, IAS, and CDSCO schemes, covering Medical Device Management Systems (ISO 13485) and Product Certification programs including IMDR (For CDSCO) and MDD (For PCBC, ITC etc)
• Conducted comprehensive technical reviews of medical device documentation in compliance with IMDR 2017 (Fourth Schedule), EU MDR 2017/745, and EU IVDR 2017/746, ensuring regulatory and scheme-specific conformity.
• Reviewed device-specific technical documentation against applicable international standards, including ISO 14971 (Risk Management), ISO 14644 (Cleanrooms), ISO 14155 (Clinical Investigation), IEC 62366 (Usability Engineering), and IEC 62304 (Medical Device Software Lifecycle).
• Performed application reviews in accordance with IAF MD 9, assessing scope, device classification, regulatory pathways, and readiness for certification activities.
• Executed technical reviews of audit reports and certification documentation to ensure compliance with ISO/IEC 17021 and applicable IAF guidance documents, enhancing robustness and accreditation acceptability.
• Maintained detailed logs and records for product technical documentation reviews and audit engagements, ensuring traceability and supporting accreditation audits.
• Co-trained ISO 13485 internal auditor course, enhancing participants' understanding of accreditation requirements.

• Manufacturing of wound healing devices (Strategy and sample batch)
• Developed SOPs aligned with OECD GLP guidelines to facilitate GLP lab approval
• Developed SOP based on ISO 10993, ISO 13485, and ISO 14971 standards.
• Formulation of the Haemostatic devices for wound care
• Handling outsourced device testing and providing the trainings on regulatory topics

GPA: 7.52 CGPA

GPA: 6.86 CGPA