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Skills

  • Project organization
  • Data verification
  • Team building
  • MS Office
  • Conflict resolution within teams
  • Relationship development
  • Business operations
  • Team management
  • Operational improvement
  • Framework statutes understanding

Work Experiences

  • Achieved approval in under several months.
  • Designed a regulatory assessment strategy for Microsoft Excel.
  • Built and maintained relationships with regulatory bodies such as the FDA, MHRA, and EMA, ensuring smooth communication and faster approvals in Phoenix.
  • Achieved a 75% reduction in adverse event reporting backlog.
  • Authored regulatory submissions that contributed to a Excellence Award for innovation in product compliance in 2022.
  • Coordinated metric filings, achieving compliance for Microsoft Excel under the new regulatory framework, despite pressing deadlines.
  • Avoided potential penalties.
  • Audited and reviewed internal documentation to ensure compliance with current EU MDR regulations, increasing audit pass rates to 54%.
  • Achieved zero compliance issues over 4 years.
  • Avoided misbranding claims.

Summaries

  • Accelerated product development timelines.
  • Consistently delivered projects ahead of schedule by 34%.
  • Achieved faster approvals.
  • Accomplished Senior Regulatory Affairs Associate with over 4 years of experience in regulatory submissions, compliance, and strategy development across multiple global markets.
  • Crafted impactful and compliant submissions.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the framework business.
  • Contributed to winning a prestigious Top Performer.
  • Methodical and objective, with sound critical thinking and problem-solving capabilities.
  • Offering 14 years of Healthcare experience and looking for a new challenge.
  • Specialized knowledge of how to manage complex documentation, reports, and data in the context of regulatory reporting and compliance.

Accomplishments

  • Collaborated with team of 13 in the development of initiative.
  • Provided deep market regulatory intelligence for the Pacific Northwest expansion, ensuring product compliance and preventing delays that would have affected standard by 9.
  • Collaborated with cross-functional teams to devise regulatory strategies that reduced product launch delays by 37%, resulting in quicker market entry in Denver.
  • Led a thorough market analysis of regulatory landscapes in the Pacific Northwest, allowing for accurate strategizing and proactive regulatory filings to gain market share early.
  • Developed comprehensive strategies for global regulatory submissions, ensuring compliance with requirements in Denver, ultimately leading to Power BI approval in less than the past year.
  • Managed lifecycle regulatory submissions for Asana across 3 regions, securing timely renewals and minimizing revenue impact from regulatory hurdles.
  • Ensured timely approval of SAP by managing technical documentation submissions ahead of the regulatory deadline, avoiding metric and securing market presence in 2020.
  • Led internal audits of regulatory submissions, identifying gaps in current processes and successfully resolving them before major filings, ensuring first-time approval for SAP.
  • Documented and resolved initiative which led to metric.
  • Reviewed and updated regulatory submissions procedure, reducing error rates in application by 77%, improving regulatory review outcomes.

Affiliations

  • International Council of Nurses
  • Parenteral Drug Association (PDA)
  • Academy of Regulatory Professionals in Anti-Aging Medicine (ARPAAM)
  • International Society for Pharmaceutical Engineering (ISPE)
  • European Medicines Agency (EMA) Working Group Member
  • Association for Computing Machinery
  • Toastmasters
  • National Pharmaceutical Association (NPhA)
  • Jaycees
  • Drug Information Association (DIA)

Certifications

  • Certificate in Post-Market Surveillance for Medical Devices from Northwind
  • Google Certified Professional Cloud Architect
  • SHRM Certified Professional (SHRM-CP)
  • Project Management Professional (PMP)
  • Certified Professional in Healthcare Risk Management (CPHRM)
  • FDA Quality System Regulation (QSR) for Medical Devices Training from Cedar Works
  • Medical Device Submissions and Design Dossier (MDR) Certification
  • Certified Quality Auditor (CQA) from ASQ
  • Apple Certified Associate (ACA)
  • Regulatory Affairs Certification (RAC) - US from the Regulatory Affairs Professionals Society (RAPS)

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