Shankara Umashankar Email & Phone Number

Safeguard Organizational Reputation & Foster a Culture of Continuous Improvement & Regulatory ExcellenceVersatile leader with comprehensive quality assurance, regulatory affairs, and operations experience in diverse industries, including medical device, in-vitro diagnostic, pharmaceutical, clinical, and biotech-related manufacturing. Skilled in partnering with cross-functional leadership to ensure all aspects of product development and delivery are performed in conformance with quality management systems and regulatory requirements. Out-of-the-box thinker adept at collaborating to develop and implement impactful business / strategic plans. Well-versed in driving system improvements and embedding principles and practices within manufacturing and operations.A minimum of 27 years of work experience in Medical Device, In-vitro Diagnostic, Pharmaceutical, Clinical, and Biotech related manufacturing industries. 12 Years’ Lead Auditor Experience in Third Party Notified Body Auditing.13 years’ experience in Corporate Internal Auditing in the field of Medical Device, Pharma, and Biotech Industries.Worked as Third Party Lead Auditor/Lead Auditor, Certification Manager, Final Reviewer for NA Medical Device Program[ MDSAP, MDD, IVDR ,MDR CE- Mark, ISO13485, ISO9001, ISO 22716, ISO 17025 Lab Assessor & GRMA (Global Retailer and Manufacturing Alliance]Key Achievements : - Led global regulatory audits across multiple regions worldwide to identify and mitigate compliance risks, resulting in 60% reduction in audit findings and regulatory violations. - Developed and implemented corrective action plans that strengthened adherence to international regulations, protecting organization from potential legal and financial repercussions. - Implemented robust risk management framework and quality assurance protocols for drug and medical device products, leading to 50% decrease in compliance issues and recalls. This proactive approach improved product safety and reliability, safeguarding patient outcomes and maintaining high industry standards.- Audited high-risk devices and drugs worldwide, minimizing compliance risk and improving patient / user safety. Analyzed internal and external pre-audit data and determined risk-based audit sampling priorities.

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  University Of Mysore

  Instrumentation And Biomedical Engineering; Information Technology; Sdlc