Rose Phan Email & Phone Number

Vancouver, Bc, Ca

Kufstein, Tyrol, Austria

• EU MDR submission support for multiple products (e.g. drug delivery device, tissue expanders, anastomotic devices/instruments, ultrasound system and microsurgical instruments)• Support by reviewing the CEP/CER, PMCPF, PMSP, Labels, STED, GSPR etc.• Support BSI notified body responses for MDR submissions• Clinical Evaluation Report Project Management Support and PMCFP creation/strategy

Vancouver, British Columbia, Canada

• Prepare complex submissions from high risk to low risk devices for first-time registrations,change notifications, and renewals internationally (e.g. APAC, ASEAN, LATAM and EMEA)• Technical file/Design Dossier maintenance and remediation• Lead and support hands-on projects for EU MDR and the international market• Apply critical thinking, regulatory strategies and make recommendations to clearlycommunicate risks and continuously improve processes

Los Angeles, California, United States

• EU MDR to MDD remediation projects (MDR Technical File, labeling etc.)• Participated and supported Quality Audits (MDR stage 1 & 2 audit, ISO13485)• Responsible for international registrations• Supported a Traditional 510K submission

Los Angeles, California, United States

• Supported EU MDR activities (e.g. create templates, STED drafting)• Submitted 6 EU MDR submissions within a 4-month timeframe• Prepared and supported international registrations

Salt Lake City, Utah, United States

• Prepared and managed projects for the EU MDR transition (e.g. STED remediation)• Project leader for CEP, CER, and PMCF survey activities for EU MDR• Managed projects in creating new labeling or revising current labeling (e.g. patient implant cards, patient information leaflet)

Salt Lake City, Utah, United States

• Prepared initial registrations, change notifications and renewals for Vascular Access devices and Kits• Worked directly with the China team to prepare registration dossiers and product technicalrequirements (PTR) documents for first-time registrations and re-registrations• Collaborated cross functionally with R&D, manufacturing, sales/marketing, QA, etc.

Burnaby, Bc

• Prepared first time registrations, change notifications and renewals for high-risk biological heart valves and accessories in the international market• Created and maintained the design dossiers/technical files and other regulatory procedures• Supported on the preparation of FDA, Health Canada and EU submissions • Worked on document authentication/legalization for submissions to international countries• Prepared applications for Certificates of Free Sale (FSC/CFG) or other certificates

Bachelor'S Degree, Health Sciences

• The Canadian Health System • Applied Health Ethics • Research Methods, Biostatistics & Epidemiology • Social, Environmental, Global.

Associate Certificate, Applied Computer Applications (Aca), Graduated With Distinction

• Technical Writing • Business Communication • Microsoft Word, Excel and PowerPoint • Web Development and Design • Visual Analytics.

Access Program, Career Development

Activities and Societies: Networking events, business seminars and workshops• Mentorship with leaders to gain valuable insight in multiple.

Associate Of Arts - Aa, Health Services

• Foundations of Health Sciences & Biology • Infectious Diseases • Mental Health and Illness • Disability and Injury • Human Ecology.