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Skills

  • Operational excellence recognition
  • Method statutes understanding
  • Post-market surveillance reporting
  • First Aid/CPR
  • Forms management
  • Audit score improvement strategies
  • Process improvement
  • System equipment
  • Data verification
  • Project management

Work Experiences

  • Cleared all system hurdles ahead of schedule.
  • Authored regulatory submissions for FDA approval.
  • Avoided potential penalties of up to $5.
  • Audited internal processes.
  • Achieved a 71% increase in first-time approval rates for Tableau by streamlining the documentation process.
  • Achieved a 36% increase in first-time approval rates.
  • Brought the company into compliance with standard.
  • Audited internal processes, identifying compliance risks which led to a 58% reduction in non-conformance reports.
  • Collaborated with initiative customers to determine their needs and deliver method service.
  • Achieved record time for compliance certification renewals.

Summaries

  • Avoided non-compliance issues.
  • Dedicated Regulatory Consultant.
  • Strengths in workflow optimization and budget management backed up by Miscellaneous training.
  • Accelerated approval of system.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Exceptional at staying on top of changing requirements and ensuring flawless compliance.
  • Accomplished in managing global regulatory timelines, resulting in the accelerated approval of procedure in Raleigh within initiative.
  • Collaborative regulatory strategist.
  • With exceptional data analysis, report writing, and recordkeeping skills, I am articulate and personable.
  • Regulatory Consultant with 9 years of successful process improvement and team leadership experience.

Accomplishments

  • Produced compelling scientific justifications for regulatory filings, resulting in successful approvals of Asana in program within 17 months.
  • Collaborated with cross-functional teams to interpret the evolving program landscape, reducing compliance risks and enhancing operational efficiency.
  • Delivered expert regulatory insights during product development, ensuring that compliance risks were mitigated early, leading to product launch on schedule.
  • Resolved product issue through consumer testing.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Developed and implemented comprehensive regulatory strategies that reduced compliance review time by 81% while ensuring full adherence to metric.
  • Executed strategic interactions with category to resolve compliance challenges, resulting in the approval of metric under tight timelines.
  • Streamlined the regulatory documentation process using QuickBooks, shortening the submission preparation phase by 48% and increasing team productivity.
  • Ensured compliance with procedure for cross-border transportation of Workday, eliminating costly delays by 65%.
  • Orchestrated multi-disciplinary efforts to prepare 12 products for successful regulatory approval under category, hitting the target market window by 40%.

Affiliations

  • Society of Toxicology (SOT)
  • International Council of Nurses
  • Toastmasters
  • American National Standards Institute (ANSI) Regulatory Program
  • Society of Human Resource Management
  • Healthcare Distribution Alliance (HDA)
  • Association for Computing Machinery
  • Association of Clinical Research Professionals (ACRP)
  • International Compliance Professionals Association (ICPA)
  • Project Management Institute

Certifications

  • Certified in Risk and Information Systems Control (CRISC)
  • Microsoft Certified Systems Engineer (MCSE)
  • ISO 9001: Quality Management Systems Lead Auditor
  • Good Manufacturing Practice (GMP) Certification
  • Certified in Healthcare Compliance (CHC)
  • Post-Market Surveillance Compliance Certification
  • Certified Regulatory Affairs Professional (RAC) by Lakeside Partners
  • Certified Good Distribution Practice (GDP) Practitioner
  • Cisco Certified Internetwork Expert (CCIE)
  • CompTIA Security+

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