Karthikeyan B

Results-oriented Regulatory and Quality Assurance Engineer with 2+ years of experience in the 
MedTech industry. Proven expertise in ensuring product quality, regulatory compliance, and patient safety. 

Authored and reviewed a wide range of Post Market Surveillance (PMS) documents for medical device 
submissions, including Product Performance Analysis (PPA), Periodic Safety Update Report (PSUR) and Health 
Canada Summary Report (HCSR) and ensuring the alignment with the respective regulatory body.
● Collaborated with cross-functional teams, including Design engineers, Clinal & medical, Marketing, regulatory 
affairs, and quality assurance professionals, to gather technical information and ensure the accuracy and 
completeness of documents.
● Prepared input checklist, source documents and collection of various documents from multiple electronic 
tools & SME for assigned products.
● Assisted in data collection activities for various BD surgery products as part of the PMS activity. Prepared and 
updated weekly status report to client.
● Delivered 20+ PMS reports for various Class IIa, Class IIb & Class III products and assisted in data collection 
and report generation.
● Contributed 80% in the preparation of Sales and Complaints of PMS reports through documentation.
● Participated in cross-functional meetings to observe and learn about the collaborative nature of various 
cross functional team in the medical device sector.
● Gained well knowledge of BD interventional and Surgery products. As well as the requirement of the 
respective regulatory market (EU MDR, US FDA, Health Canada)

B.Tech (Biomedical Engineering)