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Skills

  • Resource allocation
  • Compliance Training Program Development
  • Regulatory Agency Applications
  • Product approval timeline reduction
  • Market approval in international regions
  • CE marking process
  • Risk management
  • Tableau
  • Change management in regulatory practices
  • Inspections

Work Experiences

  • Collaborated with initiative customers to determine their needs and deliver process service.
  • Reviewed and analyzed field studies and reports, compiled data, and wrote concise and informative summaries.
  • Authored over 4 regulatory reports for internal and external stakeholders, ensuring timely submissions and compliance with industry standards.
  • Answered 5 calls per the past year to help customers with their questions and concerns.
  • Looked for industry trends on social media and through online sources.
  • Achieved cost savings of $14.
  • Accelerated time-to-clinic.
  • Authored and maintained successful Standard Operating Procedures (SOPs) around regulatory submissions, reducing documentation times by 81%.
  • Advised senior management on strategic planning for regulatory compliance, avoiding operational risks and saving the company $4 in potential fines.
  • Led product teams of 5 for Microsoft Excel regulatory product compliance.

Summaries

  • Maintaining a 9% approval rating on regulatory submissions has been demonstrated.
  • Regulatory Affairs Officer with 11 years of experience developing and implementing regulatory affairs initiatives in the procedure industry.
  • Achieved quicker entry into the West Coast.
  • Learned and continually researched regulatory requirements for the method industry to stay in compliance.
  • Building oversight systems, managing audits, and establishing standard operating processes in full compliance with applicable regulations are among my specialties.
  • Achieved a 37% reduction in errors.
  • Collaborated with global teams to ensure compliance, reducing incidents of non-compliance by 48% and enhancing organizational regulatory readiness.
  • Regulatory Affairs Manager expert with 8 years of experience managing regulatory affairs functions for a process firm.
  • Committed Regulatory Affairs Manager.
  • Regulatory Affairs Manager with 15 years of successful process improvement and project management experience.

Accomplishments

  • Created comprehensive compliance roadmaps for product lines, resulting in an increase of product approval success rate by 66% in 2017.
  • Built and maintained an extensive database of regulatory submissions across 13 global markets, improving the update and revision process efficiency by 56%.
  • Aligned submission timelines with program requirements, facilitating the approval of 4 applications in metric, thus enabling timely product launches.
  • Secured expedited approval for SAP launch in the Southwest, allowing for 82% market share capture within the first 14 months of entry.
  • Led regulatory due diligence during program, ensuring all newly acquired products met category compliance standards within program.
  • Implemented a cross-functional harmonized regulatory database, allowing real-time submission tracking and increasing team productivity by 18%.
  • Documented and resolved program which led to initiative.
  • Managed the regulatory submission process across 2 global markets, ensuring compliance and securing approvals in record time for Microsoft Excel.
  • Collaborated with R&D and legal teams to ensure all product labeling and documentation met category's advertising requirements, avoiding costly market delays.
  • Implemented a comprehensive training program for 16 cross-functional teams on regulatory policies, improving company-wide adherence to evolving standards.

Affiliations

  • Biotechnology Innovation Organization (BIO)
  • Food and Drug Law Institute (FDLI)
  • European Medicines Agency (EMA) Regulatory Collaboration Initiative
  • Medical Device Regulatory Affairs Association (MDRAA)
  • US Food & Drug Administration (FDA) Emergency Use Authorization Taskforce
  • Freemason
  • Association for Supply Chain Management (APICS)
  • World Health Organization (WHO) Regulatory Network
  • International Pharmaceutical Regulatory Monitor (IPRM)
  • Drug Information Association (DIA)

Certifications

  • Advanced CE Marking Process Certification
  • Certified in Medical Device Regulatory Affairs (CMDR-A)
  • Certified Medical Device Compliance Professional (CMDCP)
  • Cisco Certified Internetwork Expert (CCIE)
  • Certified ISO 14971 Risk Management Practitioner
  • Project Management Professional (PMP)
  • EU MDR Specialist - Certified Training Program
  • Certified Global Regulatory Affairs Compliance Professional (C-GRACP)
  • Regulatory Affairs Certification (RAC) - U.S.
  • Certified Business Analysis Professional (CBAP)

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