Rose Phan
Principal Regulatory Affairs Consultant @Q&r Meddev Consulting
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WORK HISTORY
Principal Regulatory Affairs Consultant @Q&r Meddev Consulting
Lead/support EU MDR projects including technical documentation, GSPR, CEP/CER, PMCF, labeling and notified body interactions• Support EU IVDR projects including but not limited to technical documentation, GSPR, PEP/PER, APR, IFU, labeling • Support Internal Audit activities and other various tasks
EDUCATION
Carleton University
Master of Business Administration (Online), Concentration in Management and Change
British Columbia Institute of Technology
Associate Certificate, Applied Computer Applications (ACA)
Simon Fraser University
Bachelor's degree, Health Sciences
SKILLS
ABOUT ROSE PHAN
Regulatory Affairs Leader | Medical Devices | Global Market Access | EU MDR | Quality SystemsI\'m on a mission to streamline market approvals to ensure safe, innovative medical devices reach patients worldwide. With 11+ years of experience in Regulatory Affairs for Medical Devices, I specialize in navigating complex global regulations and leading new CE-mark and transition projects under the EU MDR 2017/745 framework. What sets me apart?• I thrive in fast-paced environments, tackling complex challenges with a detailed, efficient, and solution driven mind while maintaining a positive attitude.• A strong team player and collaborator: I believe in fostering open communication, supporting cross-functional teams, and driving projects forward through collective expertise.• A proactive problem solver: I’m the type who raises my hand when a challenge arises and sees it through to completion.• A track record of successfully managing complex regulatory projects including EU MDR submissions and Global Market Submissions.Expertise: Global Market Submissions & Compliance (e.g. EMEA, LATAM, CHINA, APAC/ASEAN) MDR 2017/745: Initial CE-Mark projects and Transition projects (e.g. STED, GSPR, CEP, CER) ISO 13485, MDSAP & MDR Stage 1 and 2 Audits Technical Documentation & Design Dossier Creation and Management Notarization/Apostille/Legalization/FSC/CFG Clinical Evaluation Report & PMCF Coordination Project management experience in Regulatory and Medical Affairs Regulatory Intelligence & Strategic Compliance Planning Proficient in Microsoft Office (Microsoft Teams, Word, Excel, PowerPoint, Outlook, SharePoint, OneDrive), Zoom, Skype and Adobe Acrobat Pro Worked with platforms such as Agile, MasterControl, Greenlight, SAP, RAMS (Emergo), Quality Collaboration by Design (QCBD) and DocuShareDevice Experience:• Cardiovascular: Tissue Heart Valves, Vascular Access Devices (PICC, Ports, CV catheters)• Neurovascular: Catheters, Guidewires, Stents, Coils• Software as a Medical Device (SaMD): Ultrasound, wireless scanner for Pressure Injury• Surgical & Wound Care: Tissue Expanders, Anastomotic & Microsurgical Instruments, Wound Closure Devices• Drug Delivery: Wearable Subcutaneous Drug Delivery Systems• Neurosurgery devices and accessories: Cranial Access Kit, External Drainage system, Collection bags, Microsensors, Bipolar Forceps, cords and tubing, Surgical patties and strips Let’s connect! If you have a project or collaboration opportunity, reach out at r••••••••@mdrasolutions.com.
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