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Skills

  • Product Risk Assessments
  • Product information
  • Method statutes understanding
  • Budgeting and Cost Savings in Compliance
  • Regulatory change management
  • Data verification
  • International Regulations
  • New Regulatory Guidelines Analysis
  • Tableau
  • Negotiation with Regulatory Authorities

Work Experiences

  • Advised product teams on compliance.
  • Answered 17 calls per one year to help customers with their questions and concerns.
  • Collaborated with external legal counsel to address regulatory enforcement actions in Portland, resulting in a favorable resolution with no further penalties.
  • Collaborated with global regulatory bodies.
  • Achieved on-time regulatory submission.
  • Consumer inquiries were received, researched, and resolved by me.
  • Looked for industry trends on social media and through online sources.
  • Authored detailed regulatory reports analyzing procedure regulations, enhancing senior management's decision-making capabilities.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Transported SAP to 18 months customer locations.

Summaries

  • Outstanding public relations abilities.
  • Conducted thorough reviews of regulatory updates from metric.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Collaborative Regulatory Affairs Analyst.
  • Analytical and detail-oriented professional whose primary goal is to ensure that products meet all applicable domestic and international regulatory requirements.
  • Exceptional at staying on top of changing requirements and ensuring flawless compliance.
  • Achieved market compliance for 7 products without delays.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Adept in managing regulatory compliance across 3 jurisdictions.

Accomplishments

  • Led root cause analysis and corrective action initiatives, leading to a successful resolution of all FDA audit findings within 5 months.
  • Performed pre- and post-market surveillance audits, identifying and closing compliance gaps which reduced product retrieval instances by 40%.
  • Established a streamlined process for submitting ANDA applications, reducing submission times by 48%.
  • Led efforts to harmonize global regulatory documentation, reducing redundancy and streamlining communication between stakeholders.
  • Documented and resolved process which led to initiative.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Advised internal teams on regulatory risks and opportunities, improving corporate compliance strategies and avoiding costly penalties.
  • Monitored global regulatory trends to anticipate impacts on the company, enabling proactive adjustments to compliance strategies.
  • Collaborated with team of 14 in the development of metric.
  • Implemented corrective action plans to address audit deficiencies, leading to full compliance by framework within 3 months.

Affiliations

  • Association for Supply Chain Management (APICS)
  • International Association of Privacy Professionals (IAPP)
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • American Society of Safety Professionals
  • Project Management Institute
  • Parenteral Drug Association (PDA)
  • International Federation of Associations of Pharmaceutical Physicians (IFAPP)
  • Drug Information Association (DIA)
  • Lions Club
  • Public Responsibility in Medicine and Research (PRIM&R)

Certifications

  • Certified Compliance & Ethics Professional (CCEP) by system
  • Certified UDI Compliance Professional by Vantage
  • ISO/IEC 27001 Lead Auditor Certification
  • Microsoft Certified Systems Engineer (MCSE)
  • Certified Clinical Research Coordinator (CCRC)
  • Certified in Regulatory Intelligence by method
  • Certified Medical Device Auditor (CMDA)
  • Certified ISO 14971 Lead Risk Assessor
  • First Aid/CPR Certified
  • Master's Certificate in Global Regulatory Affairs from metric

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