Sunil Kumar Muduli

Medical Device and Pharmaceutical Regulatory Compliance Self-Employed, Freelance Professional January 2024 - Present

• Regulatory Strategy and Compliance: Specialize in comprehensive regulatory strategies for ISO 13485, GMP, GLP, and EUMDR compliance. Conduct gap analyses and remediation for alignment with FDA Quality System Regulation (QSR), EU Medical Device Regulation (MDR), and other global regulatory frameworks.
• Advanced Quality Systems Implementation: Design and implement cutting-edge quality management systems tailored for medical device and pharmaceutical manufacturing environments. Employ best practices for validation, process control, and quality assurance to exceed ISO 9001 and ISO 13485 standards.
• Risk Management and Safety Assurance: Apply ISO 14971 for advanced risk analysis and mitigation strategies in medical device development and lifecycle management, integrating risk management with overall quality systems.
• Clinical Evaluation and Oversight: Manage comprehensive clinical evaluation processes, including protocol development, site monitoring, and data integrity oversight according to ICH-GCP standards and regulatory submissions.
• Educational Workshops and Training: Lead workshops and training sessions on the latest regulatory updates, advanced quality practices, and compliance strategies, enhancing organizational capability and compliance.
• Digital Compliance Tools Expertise: Leverage digital tools and software to enhance compliance with electronic records regulations, including mastery over systems supporting 21 CFR Part 11 compliance.
• Project Leadership in Regulatory Environments: Direct cross-functional teams in project execution to ensure compliance with regulatory submissions, audits, and product approvals.
• Effective Communication with Regulatory Bodies: Maintain proactive communication with regulatory agencies to facilitate efficient product reviews, registrations, and market introductions.

• Comprehensive Audits of Quality Management Systems: Spearheaded audits across ISO 9001, ISO 13485, ICMED 9000, IMDR 2017, MDD 93/42/EEC, IVDD 98/79/EC, EU MDR 2017/745, and EU IVDR 2017/746. Ensured compliance with both domestic and international standards, upholding the highest quality benchmarks for medical device manufacturers.
• Strategic Collaboration with EU Notified Bodies: Collaborated with key EU Notified Bodies including PCBC (NB 1434), ITC (NB 1023), HTCERT (NB 2803), and MTIC (NB 0068). Conducted technical file reviews and audits, essential for compliance with European regulatory standards, facilitating efficient market entry for medical devices and IVDs.
• Leadership in Certificate Granting and Review Processes: Directed the review and authorization of certificates, particularly CE Mark certifications, making detailed, critical decisions to maintain device quality and integrity.
• Technical File and Design Dossier Expertise: Performed detailed evaluations of Technical Construction Files (TCFs) and Design Dossiers (DDs) under various standards, including the Indian MDR, ensuring comprehensive documentation met strict regulatory requirements.
• Quality Documentation Analysis and Oversight: Extensively analyzed and evaluated Quality Manuals and Quality System procedures, ensuring all documentation met certification criteria.
• Development and Delivery of Regulatory Training: Developed and led training sessions for internal teams and external clients, enhancing understanding and implementation of regulatory standards.
• Project Management and Leadership: Managed projects focusing on strategic resource allocation and team leadership, ensuring timely and successful project completions.
• Recognized Expertise and Leadership: Established as an Approved Lead Auditor, demonstrated proficiency and leadership in navigating complex regulatory frameworks for medical devices and pharmaceuticals.

• To conduct Quality Management System audits ISO 9001 & ISO 13485 audits
• Conduct Audit report reviews
• Use of harmonized standards/regulations: ISO 9001, ISO 13485

Senior Clinical Research Associate and Regulatory Officer, Eucare Pharmaceuticals
Acquired by Urgo Medical, Chennai, India
February 2018 - August 2019

• Regulatory Documentation and Compliance: Authored and maintained comprehensive regulatory documentation including Quality Management System (QMS) files, EU MDR and Indian MDR compliance files, Post-Market Surveillance (PMS) plans, and vigilance reports. Ensured all documentation aligned with stringent EU and Indian regulatory standards.
• Clinical and Regulatory Leadership: Led clinical operations ensuring compliance with medical device regulations. Managed the lifecycle of clinical studies from planning to execution, including budget oversight and CRO management.
• Innovation and Product Development: Worked closely with the R&D team to develop products aligned with market trends, contributing to innovation in devices made from animal origins, fish, collagen, gelatine, and various pharmaceutical compositions.
• Quality and Risk Management: Ensured compliance with Quality Management System (QMS) and Risk Management (RM) processes. Managed Materiovigilance activities and customer complaints, maintaining high standards in a WHO-accredited CGMP facility
• Internal Audit Execution: Conducted internal audits to ensure rigorous compliance with established quality standards and regulatory frameworks, enhancing organizational readiness for external reviews.

Proprietor, Medical Supplies Distribution
Self-Employed, Bhubaneswar, India
November 2016 - January 2018

• Sales and Distribution Management: Led marketing and distribution for a broad range of medical supplies, focusing on orthopedic implants and surgical aids in Bhubaneswar.
• Order Fulfillment and Product Expertise: Managed detailed order execution and delivery, while providing in-depth product knowledge and technical advice to customers, ensuring they received the most suitable products for their needs.
• Inventory and Product Management: Oversaw inventory control, maintained stock levels to match market demand, and stayed informed on the latest advancements in medical technology to enhance product offerings.
• Customer Engagement and Support: Delivered exceptional customer service, resolved inquiries and complaints, and educated customers on product benefits and technical specifications, reinforcing trust and customer loyalty.
• Business and Financial Oversight: Conducted all aspects of business operations, including financial oversight and strategic decision-making, to secure profitability and business growth.
• Medical Product Expertise: Demonstrated comprehensive expertise across a diverse product portfolio, including collagen products, hydrogel, and other advanced wound care solutions, enhancing client confidence and satisfaction.

Clinical Research Associate, Micro Therapeutics Research Labs, Chennai, India

• Clinical Trial Management: Executed medical writing and managed Phase II, III, and IV clinical trials, along with bioequivalence studies. Conducted site and investigator selection, feasibility evaluations, and ethics committee submissions.
• Regulatory Compliance and Monitoring: Oversaw regulatory submissions and maintained compliance with harmonized standards such as ICH-GCP, GMP, and Medical Device Directives. Conducted quality assurance audits and monitored trial activities, including protocol compliance, data integrity, adverse event management, and inventory control of investigational products.
• Product Oversight: Managed a diverse range of pharmaceuticals and medical devices, including nutraceuticals, infusion pumps, syringes, surgical instruments, and diagnostic kits.
• Standards Adherence: Ensured strict adherence to international regulatory standards, including the Indian Drugs and Cosmetics Act, Schedule-Y guidelines, MEDDEV norms, and 21 CFR part 11.