Rose Phan Email & Phone Number

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 and.

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

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

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 and.