beBee background
Professionals
>
Toronto
Aishwarya Venkatasubramanian

Aishwarya Venkatasubramanian

RA/QA Specialist

Pharmaceutical / Bio-tech

Toronto, Ontario

Social


Social Networks

Services offered

A highly motivated and detail-oriented professional seeking a challenging and rewarding career in Regulatory Affairs and Quality Assurance. With a strong academic background and a passion for ensuring compliance with regulatory guidelines, I aim to contribute my expertise in navigating complex regulatory landscapes to support the development and marketing of safe and effective products. 

Approximate rate: CAD$ 30 per hour

Experience

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

Education

Pursuing PGDP in Regulatory Affairs and Quality Assurance from AAPS

Professionals in the same Pharmaceutical / Bio-tech sector as Aishwarya Venkatasubramanian

Professionals from different sectors near Toronto, Ontario

Other users who are called Aishwarya

Jobs near Toronto, Ontario

  • Net2Source (N2S) Toronto

    We are hiring "Systems Testing/QA Specialist – Senior" for one of our clients. · We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare... · ...

  • QA Specialist

    2 weeks ago

    Skelton Truck Lines Sharon, ON

    The Quality Specialist assists in the implementation of quality programs. · Post-secondary education3 years of related working experienceFamiliarity with GMP,GPP,GCP and/or any ISO quality management system is an assetExperience investigating deviations is required/li> ...

  • S M Software Solutions Inc Toronto

    We are seeking a highly experienced Senior Systems Testing/QA Specialist for the Ministry of Public and Business Service Delivery and Procurement.This onsite opportunity leads comprehensive testing for ReST-based transactional web services, API automation with ReadyAPI/SoapUI/Pos ...