Varun S. - 16257 Regulatory Affairs Associate from Toronto

I have 2 years working in health regulated industries involving medical devices, cosmetics, and pharmaceuticals to oversee product lifecycle into market without compromising on industry-specific functionality, quality, and regulatory compliance. As a Biotechnology and Regulatory Affairs graduate with a strong focus on integrity and ethical business practices, I am confident that my experience contributing within the medical device industry along with my strong communication and collaboration skills makes me the perfect fit for this role. Working as a Quality Assurance intern at GAO Tek, I have performed audits of products and collected samples of raw materials as required with GMP and ISO standards along with all applicable company policies. I have demonstrated my abilities to be vigilant to ensure all quality levels are met by monitoring critical control points, key performing indicators, and safety throughout the manufacturing process. As a result, I have learned the importance to be highly detail-oriented and to effectively coordinate with managers & support staff while working in a dynamic & fast-paced, team environment. Furthermore, as a Risk Analyst at Hatch Ltd working, I was able to enhance my organizational skills by developing risk reports from multitude of varying-sized projects for our clients, along with maintaining the risk register within Hatch’s database. In addition, I maintained exceptional interpersonal skills and entrepreneurial thinking to develop healthy relationships with suppliers and clients. As the Risk Analyst, I gained valuable knowledge of technical report writing and made effective changes to eliminate production issues and reduce errors. During my most recent work experience as a Regulatory Affairs Associate at Abbott Medical, I’ve prepared over 5 technical electronic submission dossiers ensuring timeliness, accuracy, and compliance with all regulatory agencies (Health Canada and FDA) to achieve product clearance consistently. I’ve learned to successfully collaborate and interact with different disciplinary groups to advance marketing strategies, pre-submission strategies, & regulatory pathways. Thank you in advance for reviewing my candidacy for this position. Sincerely, Varun Sinnathamby