Pritam Mekala

Create and Manage a portfolio of >20 Cardiovascular and Vascular Medical device companies .

Spearheaded regulatory strategies for medical devices, ensuring compliance with EU, FDA, TGA, ANVISA, JAPAN, Health Canada, and global standards with focus on food safety and quality.

Develop deliverables such as Clinical Investigation Reports/ Plans (US), CERs, Tech Documentation, PMS Reports, etc. per relevant MDCG guidance in over 10 regions.

Assess and discuss pre-submission regulatory strategy for high-risk medical devices (class III) with clients and conduct Quality System and Manufacturing related audits .

Implemented risk management and quality assurance processes, reducing compliance gaps by 25% through proactive monitoring and SOP development .

Proactively engaged in project management to align with budget and client expectations, enhancing client satisfaction – Interface with functional experts and clients.

Regulatory Affairs Leader with 15 years of experience in medical device industry – Cardiovascular Interventions, Spinal Products, Peripheral Vascular Catheters, Animal & Human Origin Devices. Expert in navigating US FDA, Health Canada, EU MDR/IVDR, MDSAP and other international regulatory frameworks. Proven ability to lead cross-functional teams, manage complex submissions, and drive quality assurance initiatives with specialized expertise in device testing and certification.

Decade+ track record in CE mark approvals, regulatory submissions, lifecycle management, and cross-functional collaboration.

Master’s in business development & Innovation for Medical Devices

Business School of RWTH Aachen University – Germany, EU Jan 2025

MIT xPRO - Project Management: Leading Organizations to Success

Massachusetts Institute of Technology – Cambridge, MA, USA Jan 2023

Master of Technology in Biomedical Engineering (Cardiovascular Interventions)

University of Minnesota – Minneapolis, MN, USA Jan 2018

M.S. in Mechanical Engineering

Oklahoma State University – Stillwater, OK, USA July 2013