Heejin Park

Canadian immigration professional with hands-on experience managing complex, time-sensitive immigration matters from application preparation through post-submission case resolution. Managed 143 Canadian immigration applications, with 96 approved and a 90.6% approval rate among completed cases, while currently managing 32 active files. Experienced in identifying case-specific issue identification, supporting evidence review, written submissions, reconsideration requests, IRCC correspondence, and deadline-driven file management.

Combines

Canadian immigration experience with prior experience in a highly regulated medical device environment, where regulatory applications, compliance documentation, regulatory responses, quality control, and time-sensitive submissions required accuracy, consistency, and careful attention to detail.

Immigration Department | Administrative Assistant at E Leaders Consulting Inc. (2025-01 – Present)

Immigration consulting firm providing end-to-end support for immigration processes

• Prepare and submit Canadian immigration applications by identifying required forms and supporting documentation
• Draft and submit supporting letters and written explanations for immigration applications, including explanation letters, recommendation letters, and reconsideration letters submissions for temporary resident and H&C matters
• Create and manage EE profiles, including reviewing client information and supporting documentation for accuracy and completeness
• Manage post-submission communications with IRCC through Web Forms, including additional document submissions, reconsideration requests, work authorization requests, requests to change the principal applicant, and follow-ups on delayed application decisions
• Coordinate refusal case resolution by reviewing refusal reasons, identifying deficiencies, preparing supporting documentation, and determining appropriate next steps, including reconsideration requests or reapplication
• Conduct detailed quality checks of application packages to verify completeness, accuracy, consistency, and regulatory compliance of supporting documents prior to submission
• Manage multiple client immigration files simultaneously, tracking required documents, application stats, follow-up actions, and filing deadlines to ensure timely submission
• Key Achievement: Successfully managed 143 immigration applications (96 approved, 32 in progress, 5 withdrawn)

R&D Center | Regulatory Affairs Specialist at CusMedi Co.,Ltd. (2021-01 – 2024-03)

Developer and manufacturer of Patient-Specific-Implant (PSI) using titanium powder and 3D printer

• Managed regulatory affairs activities for Class II and III implantable medical devices, ensuring compliance Food and Drug Administration (FDA/U.S.), European Conformity (CE/EU), and Ministry of Food and Drug Safety (MFDS/Korea) requirements
• Identified required documentation, prepared regulatory applications and supporting documents, and submitted application packages to regulatory authorities
• Reviewed deficiency notices and regulatory inquiries, coordinated required supporting information, and prepared responses throughout the regulatory approval process
• Maintained controlled quality and regulatory documentation, including Design History Files, Device Master Records, technical documentation, and manufacturing records, to support ISO 13485 compliance
• Monitored changes to applicable regulatory requirements and supported updates to internal procedures and quality documentation to maintain compliance
• Coordinated cross-functional activities among regulatory, quality, R&D, manufacturing, and testing teams to ensure required documentation and processes met applicable regulatory and quality requirements
• Key Achievement: Successfully submitted two Class II implantable medical devices to FDA (510(k)), and achieved MFDS approval for six Class II/III implantable medical devices

Bachelors of Science in Engineering in Division of Computer Engineering – University of Baekseok (2021-02)