Manicka Sundaram

Manicka sundaram R is a seasoned regulatory and compliance professional with over 16 years of experience, including a decade in the medical device industry.

He specializes in design history file remediation, risk management, and compliance with global regulatory standards. He has successfully supported global manufacturers in achieving EU MDR compliance through strategic regulatory expertise.

In addition to his regulatory expertise, Manicka has strong experience in Project Management Office (PMO) functions, driving structured project execution, governance, and cross-functional coordination, with hands-on experience in tools such as Zoho for project tracking and workflow management.

He brings deep capabilities in automation, macro development, data analysis, and data visualization, enabling efficient and scalable regulatory operations.

Manick is passionate about transforming complex and repetitive regulatory tasks into streamlined, time-efficient solutions, leveraging his industry experience to deliver impactful outcomes for clients.