Rose Phan Email and Phone Number
Rose Phan work email
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Rose Phan personal email
My name is Rose Phan and I'm on a mission to make the world a better place. I'm the type of person that always puts up their hand when there's a project that needs help and I always follow through and do my best. I am an organized, detail-oriented Regulatory Affairs Professional with a passion in the health and technology sector. I have 10+ years of experience working in the Medical Device Industry. Throughout my career, I have been driven to deal with numerous complex challenges in a fast paced environment while maintaining a positive attitude and work ethic.My specialties:• Expert in the International Market submissions (e.g. EMEA, LATAM, CHINA, APAC/ASEAN) • Project management experience in RA and Medical Affairs/Clinical• EU MDR Transition projects (e.g. STED, GSPR, CEP, CER, PMCF, MDR Stage 1 and 2 Audit)• Clinical Evaluation Plan and Reports Regulatory support• PMCF coordination activities such as surveys • Types of Devices:
Suma Medtec Gmbh
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Regulatory Affairs ConsultantSuma Medtec Gmbh Oct 2022 - PresentKufstein, 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
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Regulatory Affairs ConsultantMdra Solutions Inc. May 2019 - PresentVancouver, 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 -
Regulatory Affairs ConsultantBruin Biometrics, Llc Aug 2022 - Aug 2023Los 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 -
Regulatory Affairs ConsultantBalt Usa Jul 2021 - Dec 2022Los 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 -
Eu Mdr Regulatory Affairs ConsultantBd Jul 2020 - Dec 2022Salt 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) -
Sr. International Regulatory Affairs ConsultantBd Jun 2019 - Jun 2020Salt 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.
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Regulatory Affairs AssociateLivanova Jun 2014 - Feb 2019Burnaby, 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
Rose Phan Skills
Rose Phan Education Details
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Health Sciences -
Graduated With Distinction -
Burnaby Board Of TradeCareer Development -
Health Services
Frequently Asked Questions about Rose Phan
What company does Rose Phan work for?
Rose Phan works for Suma Medtec Gmbh
What is Rose Phan's role at the current company?
Rose Phan's current role is Regulatory Affairs Consultant | International Regulations | Project Management | Helping Medical Device companies through the EU MDR Transition.
What is Rose Phan's email address?
Rose Phan's email address is ro****@****rin.com
What schools did Rose Phan attend?
Rose Phan attended Simon Fraser University, British Columbia Institute Of Technology, Burnaby Board Of Trade, Langara College.
What skills is Rose Phan known for?
Rose Phan has skills like Teamwork, Time Management, Event Planning, Social Media Marketing, Project Management, Technical Documentation, Networking, Regulatory Affairs, Medical Devices, Healthcare, Microsoft Excel, Iso 13485.
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