Aishwarya Venkatasubramanian

Regulatory Affairs / Quality Assurance Associate                                               June 2023-Present

Canadian Hospital Specialties Limited, Oakville, Ontario, Canada

Responsibilities:

• Led and managed the regulatory submissions process for medical device product lines, ensuring compliance with Health Canada regulations and guidelines
• Prepared, reviewed, and submitted Class II medical device applications, including medical device new license applications and amendments (faxbacks)
• Collaborated with cross-functional teams, including R&D, quality assurance, and clinical affairs, to gather necessary technical and clinical data for regulatory submissions
• Conducted thorough research and analysis to assess the regulatory impact of new product addition for the medical device product portfolio
• Acted as the primary point of contact with Health Canada and responded to queries during the review process to facilitate product approvals
• End-to-end management of low priority medical device complaints and recalls, including coordinating with relevant departments, preparing recall communications, and ensuring timely execution of corrective actions in compliance with Health Canada regulations
• Interfaced with Health Canada as the primary contact for recall and complaint-related matters, ensuring prompt and accurate reporting of adverse events and timely resolution of regulatory inquiries
• Maintained accurate records and documentation of recall and complaint investigations, ensuring comprehensive and audit-ready documentation

Pursuing PGDP in Regulatory Affairs and Quality Assurance from AAPS