Student Testimonial - Kulwinder N

Name: Kulwinder N
Program: Health Sector Regulatory Compliance
Graduate: 2022

Tell us what you’re doing workwise right now.

I am currently employed at Boston Scientific as Quality Assurance & Vigilance Reporting Analyst. Boston Scientific is a leading medical device company that is dedicated to transforming lives through innovative medical solutions improving the health of patients around the world. I specifically work in the Cardiology division, Post-market Product Performance department. My day-to-day role includes review of complaint communications and I assess for regulatory compliance, report ability, and potential impact to patient safety and business operations. I investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis. I also communicate with internal/external customers to obtain all available information for each complaint event to ensure complaint records, regulatory reports, and applicable complaint handling documents are compliant with Good Documentation Practices (GDP), global regulatory standards and internal procedures. I write Medical Device Reports (MDRs), vigilance reports, and other regulatory reports, ensuring timely transition to the appropriate regulatory authorities.

Reflect on your time just prior to Humber. Why did you choose Humber College? What was your career ambition?

Prior to Humber I graduated as a Biomedical Engineer and with many years of work experience, I wanted to continue pursuing my career in the healthcare sector specifically in medical devices. I was working in an automation robotics company where I was handling their internal complaints management system for any non-conforming products. This made very curious to learn how exactly a quality system is designed in order to monitor the post market of a health industry to prevent such deviations. I decided for a development change and carry forward my current skills specifically in a health sector quality related role to contribute towards an organization that helps save patient lives. The Health Sector Regulatory Compliance program at Humber was one of the unique programs which offered a combination of courses that anyone can apply in the industry of quality and compliance. It focused on various industries such as food, pharmaceuticals, medical devices, cannabis, etc. The program also covered ethics, auditing, risk management and supply chain, offering students a deep dive into knowledge of business operations.

How did the program set you on your path to where you are now?

This program did not just focus on theory but also on practical approach when someone is in a quality compliance role. Participating in class discussions related to auditing and risk assessments boosted my confidence and helped me build great interpersonal skills which I now apply every day liaising with team members as well different departments. By completing my individual research project on Home-use Medical Device Safety, it gave me a great exposure and understanding about medical device regulations and insights on ISO 13485 (International Organization for Standardization 13485 Quality Management System for Medical Devices). I have been able to apply my educational knowledge as a practical foundation to achieving higher quality standards by being a strong team player.

What advice would you share to someone considering this field?

As a quality compliance professional, I do not follow quality just as a procedure only to meet the requirements or standards, but rather I bring quality into my work. I must understand that quality is not about testing a finished product, it is about planning and designing a system for a product in a step-by-step manner right at the beginning of a process all the way to the well-being of the end user. I encourage you to collaborate with your team members as well with other departments, to try to define, analyse, improve and control a process from start to finish. Do not work as an individual, work as a team together to meet organizational goals. The stronger the culture is, the stronger it serves as the backbone for achieving excellence. Excellence will bring high ethical values in the team which will reflect confidence, credibility and customer trust in your product or your service you provide.