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Skills

  • Project management
  • Global regulatory requirements knowledge
  • Project organization
  • Regulatory compliance
  • Regulatory documentation review
  • First Aid/CPR
  • Customer service
  • Forms management
  • Regulatory dossier preparation
  • Compliance with evolving standards

Work Experiences

  • Answered 5 calls per 6 months to help customers with their questions and concerns.
  • Oversaw the delivery of category project by process team, which resulted in framework.
  • Achieved timely approval of SAP in the Southwest.
  • Achieved a 16% increase in approval efficiency.
  • Authored regulatory documents across 6 countries.
  • Authored and reviewed regulatory documents across 6 different countries, ensuring comprehensive accuracy in technical dossiers.
  • Achieved approval ahead of deadlines by 3 months.
  • Boosted regulatory submission success rates by 49%.
  • Achieved regulatory approval for Microsoft Excel.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.

Summaries

  • Exceptional at staying on top of changing requirements and ensuring flawless compliance.
  • Contributed to a 57% reduction in non-compliance cases.
  • Committed to compliance excellence, maintaining a comprehensive regulatory intelligence database that supports real-time decision-making across 7 international markets.
  • Dedicated to learning, growing, and succeeding in Healthcare.
  • Achieved a 44% efficiency gain in submissions.
  • Outstanding public relations abilities.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the procedure business.
  • Clear understanding of strategic planning and budget management as well as cross-functional collaboration training.
  • Regulatory Affairs Assurance Associate with 18 years of successful risk assessment and budget management experience.
  • Strengths in performance reporting and project management backed up by Healthcare training.

Accomplishments

  • Acquired in-depth knowledge of ServiceNow-specific testing and approvals for entry into the Southeast, reducing rejection rates by 70%.
  • Implemented a document management system for regulatory records, increasing document retrieval accuracy by 25%.
  • Trained 9 team members on regulatory submission best practices introduced during 2016, improving submission accuracy by 33%.
  • Interpreted and applied regulatory guidelines from the Northeast, ensuring compliance across 2 product lines in method.
  • Led the regulatory document harmonization process across 5 regions, ensuring consistency in product claims and requirements.
  • Monitored changes in the Pacific Northwest regulatory policies and updated corporate guidelines, ensuring compliance within 16 months.
  • Reviewed and approved marketing materials to ensure compliance with regulatory standards for Microsoft Excel, preventing potential product recalls.
  • Created standard operating procedures (SOPs) for regulatory submission processes, leading to a 43% reduction in submission errors.
  • Provided strategic regulatory advice for the launch of QuickBooks in the Midwest, enabling timely market entry within 18 weeks of approval.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.

Affiliations

  • Association for Supply Chain Management (APICS)
  • Society for Clinical Data Management (SCDM)
  • Association of Information Technology Professionals
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH)
  • Healthcare Compliance Certification from Lakeside Partners
  • Canadian Association of Professionals in Regulatory Affairs (CAPRA)
  • European Medicines Agency (EMA) Working Group Memberships
  • Regulated Local Industry Group Membership for the Southwest
  • Freemason
  • Toastmasters

Certifications

  • SHRM Certified Professional (SHRM-CP)
  • Certified in Risk and Information Systems Control (CRISC)
  • Pharmaceutical Regulatory Affairs Certification (PRAC) – Austin
  • CompTIA Network+
  • Cisco Certified Network Associate (CCNA)
  • Google Certified Professional Cloud Architect
  • Certified Clinical Research Professional (CCRP) - 2017
  • Risk Management in Regulatory Systems Certification – Meridian
  • ISO 13485 Lead Auditor – Harbor & Co.
  • ServSafe

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