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Skills

  • Clinical Trials Protocols
  • FDA Submissions (510(k), PMA)
  • Application coordination
  • ISO Standards
  • International regulatory submissions
  • SAP EHS Management
  • Global market entry strategy
  • Product Life Cycle Management
  • Compliance training facilitation
  • Global Regulatory Compliance

Work Experiences

  • Collaborated with governance committees on the development and evaluation of plans.
  • Led product teams of 15 for QuickBooks regulatory product compliance.
  • Achieved 4 successful trial initiations.
  • Helped with system regulatory product compliance initiatives.
  • Advocated for the prioritization of project-related tasks, such as category, in order to efficiently complete critical tasks.
  • Reviewed and analyzed field studies and reports, compiled data, and wrote concise and informative summaries.
  • Chaired regular cross-functional regulatory strategy meetings, keeping leadership informed of potential compliance risks.
  • Was in charge of all regulatory requirements for products like metric, framework, and method.
  • Was in charge of managing fees and applications, as well as tracking product progress and responding to regulatory inquiries.
  • Built a collaborative relationship with key stakeholders during submission development, improving the approval rate by 85%.

Summaries

  • Achieved zero compliance audit findings for Workday in 2022.
  • Records of regulatory information and submissions were kept and followed up on.
  • Accomplished Regulatory Affairs Officer driving compliance for global regulatory submissions with an eye for detail and risk management, minimizing market delays across 16 countries.
  • Compliance expert with extensive experience.
  • Achieved zero additional requests for information on QuickBooks.
  • Achieved timely approvals in competitive markets.
  • Consistently deliver actionable insights.
  • Coordinated global regulatory submissions.
  • Achieved 45% faster approvals.
  • Achieved consistent market renewals.

Accomplishments

  • Collaborated with team of 7 in the development of category.
  • Streamlined regulatory submission processes through automation of routine tasks, realizing an 47% efficiency gain.
  • Authored and reviewed product labeling to meet both FDA and EU regulations, resulting in successful launch in 2022.
  • Managed communications between regulatory bodies and internal departments, improving issue resolution speed by 72%.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Developed and launched a compliance training program for system staff, improving audit preparedness by 46%.
  • Improved post-market surveillance systems, ensuring 55% reduction in compliance violations over 6 months.
  • Successfully implemented standard operating procedures to improve regulatory consistency, reducing pre-submission rework by 20%.
  • Led a cross-functional team to submit a regulatory dossier by standard, hitting milestone with 36% error-free submissions.
  • Documented and resolved procedure which led to process.

Affiliations

  • Good Clinical Practice (GCP) Training Programs Organizer
  • The Organization for Professionals in Regulatory Affairs (TOPRA)
  • Healthcare Compliance Association (HCCA)
  • Biotechnology Innovation Organization (BIO)
  • Regulatory Affairs Professionals Society (RAPS)
  • Association of Clinical Research Professionals (ACRP)
  • International Society for Pharmacovigilance (ISoP)
  • International Pharmaceutical Federation (FIP)
  • Jaycees
  • Project Management Institute

Certifications

  • Medical Devices Regulatory Affairs Certification - process
  • Certified Clinical Regulatory Affairs Specialist (CCRAS) - Cedar Works
  • Cisco Certified Network Associate (CCNA)
  • Microsoft Certified Systems Engineer (MCSE)
  • ISO 27001: Information Security Management Systems (ISMS) Lead Auditor
  • CompTIA Network+
  • ServSafe
  • International Regulatory Compliance Certification (IRCC)
  • Certified Public Accountant (CPA)
  • Certified Pharmaceutical Regulatory Professional (CPRP)

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