Regulatory and quality assurance engineer
Send a job offer directly to this candidate
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)
