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Skills

  • Retail Marketing
  • Tactical planning
  • Supply chain optimization
  • Customer service
  • Compliance Auditing and Gap Analysis
  • Internet and E-mail Marketing 
  • RFI Scanners
  • Supervision
  • Security systems
  • Planning and coordination

Work Experiences

  • Collaborated with Medical Device Consultants and Medical Device Consultants to plan marketing activities aimed at promoting Asana successfully.
  • Met with advertising managers to develop and implement marketing plans.
  • Collaborated with sales, service, finance, and logistics to influence critical business growth outcomes.
  • Achieved approval of HubSpot 17 months ahead of schedule.
  • Increased the category segment product margin by 16% for Phoenix.
  • Directed and launched 6 product additions in order to expand into new markets, resulting in $11 in additional sales volume.
  • Collaborated with members of the product development team to improve product specifications.
  • Coordinated marketing, sales, and IT processes to align activities with corporate goals.
  • Optimized profitability to meet marketing objectives and drive product line growth from concept to product life cycles.
  • Achieved CE marking in 8 months.

Summaries

  • Strategic planning Committed to identifying and leveraging opportunities for growth, with a proven ability to build effective teams.
  • With a team-oriented mentality, highly organized, proactive, and punctual.
  • Multilingual and fluent in Japanese and Spanish, with a strong grasp of cultural differences.
  • Accomplished Medical Device Consultant known for streamlining product lifecycle management and reducing time to market by 2 weeks for innovative products.
  • Medical Device Consultant and team leader with 2 years of experience in program settings.
  • Achieved Top Performer after launching a Class III device.
  • Motivating leader who has built and managed method teams in the past.
  • Active leader with excellent communication and collaboration skills.
  • Six Sigma certified
  • Medical Device Consultant is a creative and forward-thinking Medical Device Consultant who is ready to put her 13+ year of experience to work advancing market share for method products.

Accomplishments

  • Collaborated with clinical and regulatory experts to ensure product labeling met both FDA and process guidelines, preventing costly delays in market entry.
  • Automated compliance risk documentation for regulatory inspections, reducing audit preparation time by 59%. This led to a successful FDA inspection with no observations.
  • Created a targeted product launch plan focused on the Pacific Northwest market, resulting in 11 additional sales in the first 6 months.
  • Guided the regulatory submission process, contributing to the approval of a Class III medical device in the Southeast, which positively impacted the company's expansion into new markets.
  • Represented the company in FDA pre-market meetings as a subject matter expert, which expedited the pathway for product registration by 45%.
  • Spearheaded the localization of patient education material in the Midwest, which improved customer feedback scores by 61% and increased product adoption rates.
  • Championed the introduction of usability testing protocols, improving user interaction with the device and decreasing product returns by 40% after 16 months post-launch.
  • Redesigned global product distribution strategies, leading to a savings of 6 due to reduced shipping costs while maintaining compliance with international healthcare regulations.
  • Developed clinical trial data analysis frameworks used for successful FDA submission of a Class II medical device, receiving regulatory clearance in 2022.
  • Generated key partnerships with clinical evaluation centers, leading to improved study designs that supported FDA approval for a novel device in 2024.

Affiliations

  • Member, International Organization for Standardization (ISO) Working Group on Medical Devices
  • Certification Holder, ISO 14971 Risk Management Certification
  • Treasurer, Society of Manufacturing Engineers (SME) – Medical Device Chapter
  • Member, Advanced Medical Technology Association (AdvaMed)
  • Authorized Participant, European Medical Device Regulations (EU MDR) Compliance Workshops
  • Consultant Member, Global CAPA Council for Medical Devices
  • Professional Member, Association for the Advancement of Medical Instrumentation (AAMI)
  • Certification Holder, Lean Management in Medical Device Manufacturing
  • Peer Reviewer, Journal of Medical Device Technology and Developments
  • Affiliate Member, Institute of Electrical and Electronics Engineers (IEEE) Engineering in Medicine and Biology Society

Certifications

  • Salesforce
  • Global Regulatory Affairs Compliance Certificate - Summit Group, 2018
  • SHRM Senior Certified Professional (SHRM-SCP)
  • SHRM Certified Professional (SHRM-CP)
  • Certified Specialist in Health Technology Assessments (HTA) - framework, 2023
  • CompTIA Network+
  • Certified Corrective and Preventive Actions (CAPA) Leader - process, 2018
  • Certified Professional in Medical Device Regulatory Affairs (RAC) - 2020, Austin
  • Certified Biomedical Equipment Technician (CBET) - International Certification Commission (ICC), 2019
  • Certified Specialist in FDA 510(k) Submissions - Ironclad Systems, 2019

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