Divya Patel

Regulatory Affairs Specialist @Profound Medical Inc.

Mississauga, ON, CA

Contribute to a positive, high-performance work culture.• Provide guidance to internal stakeholders to maintain compliance with domestic and international device regulations.• Ensure that all (investigational and marketing submissions) domestic and international regulatory submissions are prepared and submitted accurately, completely, and in a timely manner to meet business objectives. Follow-up, track and assemble regulatory responses to regulatory agencies in a timely manner and or as required.• Organize and maintain regulatory files. Assure that appropriate maintenance of registrations occurs including renewals, establishment license, device listings, site registrations, supplements for changes, annual reports etc.• Provide regulatory guidance to internal stakeholders during the import and export of the devices.• Participate in the review of processes and or product design changes, labeling, claims, complaints, etc, to determine the need for any regulatory activities and to ensure compliance with regulatory requirements.• Maintain product UDI listings in country-specific databases.• Support external regulatory agency audits, providing regulatory input to minimize the potential for findings of non-compliance.• Participate in post-market surveillance activities for marketed products.• Lead the preparation and execution of Field Action activities.• Assist in fulfilling requirements of the Person Responsible for Regulatory Compliance under the EU MDR 2017/745.• Maintain QMS procedures related to regulatory responsibilities, product licensing, and regulatory reporting.• Assist with other duties, as assigned.

Institute of Good Manufacturing Practices India (IGMPI)

Post graduate diploma in medical device management

Gujarat Technological University, Ahmedbabd

Bachelor of Pharmacy - BPharm

Gujarat Technological University, Ahmedbabd

Master of Pharmacy

Northeastern University, Toronto Canada

Master's degree