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Skills

  • Customer-focused compliance solutions
  • Communications
  • Leadership in compliance remediation
  • Adverse event reporting management
  • Problem resolution
  • Issue resolution in clinical trials
  • Program statutes understanding
  • First Aid/CPR
  • Relationship development
  • Process improvement

Work Experiences

  • Achieved 12 successful approvals.
  • Completed within 2015.
  • Collaborated with quality assurance.
  • Collaborated with R&D and Quality teams.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Achieved 9 approved filings.
  • Authored and managed 12 pre- and post-market submissions, yielding a 28% reduction in submission rejection rates.
  • Achieved expedited approval from system.
  • Consumer inquiries were received, researched, and resolved by me.
  • Collaborated with external regulatory consultants to streamline the compilation of technical files, which resulted in approval times of 6 months.

Summaries

  • Outstanding public relations abilities.
  • Collaborative leader who excels at coordinating with global stakeholders to navigate complex regulatory landscapes, securing approvals in 9 new regions.
  • Addressed issues from a standard inspection.
  • Experienced in preparing and submitting regulatory documents, including reviewing materials, technical data, and filing accuracy.
  • Senior Regulatory Affairs Specialist with 3 years of successful vendor management and quality assurance experience.
  • Authored more than 17 successful pre- and post-market submissions, reducing rejection rates by 69% and improving the approval process.
  • Exceptional at staying on top of changing requirements and ensuring flawless compliance.
  • Specialized knowledge of how to manage complex documentation, reports, and data in the context of regulatory reporting and compliance.
  • Analytical and detail-oriented professional whose primary goal is to ensure that products meet all applicable domestic and international regulatory requirements.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the metric business.

Accomplishments

  • Developed a comprehensive global regulatory strategy for QuickBooks, resulting in expedited approval in 5 key markets.
  • Managed post-market surveillance to ensure ongoing compliance, successfully resolving 3 adverse event reports across multiple products.
  • Documented and resolved metric which led to procedure.
  • Advised cross-functional teams on regulatory requirements, achieving compliance certificates for QuickBooks in the Midwest within two years.
  • Played a pivotal role in obtaining Class III medical device approvals for products in Austin, resulting in new market entry within 18 months.
  • Coordinated global regulatory submissions, achieving timely approvals for 18 medical devices in 4 regions.
  • Implemented strategies that reduced regulatory submission rejection rates by 45%, optimizing timelines for market release.
  • Assessed and resolved 10 adverse event reports, ensuring full compliance with FDA post-market surveillance requirements.
  • Mentored junior regulatory staff, resulting in faster onboarding processes and a 33% increase in submission accuracy in 2022.
  • Authored and submitted 12 De Novo requests leading to successful FDA clearance of initiative.

Affiliations

  • American Medical Informatics Association
  • Jaycees
  • American Society of Safety Professionals
  • Affiliate, Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee
  • Food and Drug Law Institute (FDLI) Affiliate
  • Volunteer, Society of Quality Assurance (SQA)
  • Mentor, Women in Regulatory Affairs Leadership Forum
  • Rotary International
  • Member, International Pharmaceutical Regulators Programme (IPRP)
  • Association of Clinical Research Professionals (ACRP)

Certifications

  • Certified Compliance & Ethics Professional (CCEP)
  • Medical Device Regulatory Affairs Certification by Beacon Labs
  • ISO 13485 Auditor Certification
  • Masterclass in EU MDR and IVDR Regulations
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Regulatory Affairs Associate (CRAA)
  • Certified RA Pre-market Specialist
  • Certified Clinical Research Professional (CCRP)
  • ServSafe
  • CompTIA Network+

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