Karthik Dhanaraj

About Karthik Dhanaraj

Recognized throughout the career to leveraging in-depth knowledge (20+ Years of…

Experience

1. General Manager - Quality Assurance and Regulatory Affairs (Medical Devices)

   Evolutis

   Oct 2025 — Present · Bengaluru, IN

   With extensive experience in the medical device sector, bring a strategic focus on building and leading high-performing quality and regulatory teams, aligning operational excellence with global compliance standards. My responsibilities will include:Strategic Leadership: Developing and executing quality and regulatory strategies aligned with our business objectives, managing departmental budgets, and fostering cross-functional collaboration across R&D, manufacturing, and marketing.Regulatory Compliance: Overseeing global regulatory submissions, maintaining compliance with India MDR, EU MDR, ISO 13485, and other applicable standards, and staying abreast of evolving regulatory landscapes.Quality Management: Establishing and maintaining a robust QMS, managing internal audits, CAPA processes, and validation activities to ensure product and process integrity.Product Lifecycle Oversight: Supporting regulatory aspects throughout product development, ensuring compliant labeling and promotional materials, and managing post-market surveillance and clinical investigations.Risk Management: Implementing proactive risk mitigation strategies to uphold the safety, quality, and efficacy of our medical devices.

Education

• Ponnaiyah Ramajayam Institute of Science & Technology, Thanjavur

  Doctor of Philosophy (PhD)

• Periyar University

  Bachelor of Science (BSc)

• St. Joseph's College (Autonomous), Tiruchirappalli

  Master of Science (MSc)

• Bharathidasan University (BDU), Tiruchirappalli

  Master of Philosophy - MPhil

• Madurai Kamaraj University

  Master of Business Administration - MBA