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Skills

  • First Aid/CPR
  • Good Manufacturing Practices (GMP) understanding
  • Problem resolution
  • Communications
  • Process compliance
  • CE Mark certification process
  • Forms management
  • Relationship development
  • Technical documentation
  • Creation of risk management files

Work Experiences

  • Achieved zero findings from quality audits.
  • Achieved results over 6 months.
  • Consumer inquiries were received, researched, and resolved by me.
  • Addressed and resolved queries within one year.
  • Acted as the primary liaison for standard audits.
  • Collaborated with R&D and Quality Assurance teams.
  • Looked for industry trends on social media and through online sources.
  • Advised internal teams on regulatory changes.
  • Had an excellent attendance record and was always on time for work.
  • Coached junior staff on regulatory affairs.

Summaries

  • Collaborated with both R&D and Quality Assurance teams to ensure rigorous adherence to FDA and EMA guidelines throughout the entire product development lifecycle.
  • Outstanding public relations abilities.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Achieved 19% improvement in submission efficiency.
  • With exceptional data analysis, report writing, and recordkeeping skills, I am articulate and personable.
  • Demonstrated ability to execute gap analyses on submission requirements and implement corrective actions, strengthening compliance readiness by 24%.
  • Accelerated clinical and commercial progress for key assets.
  • Exceptional at staying on top of changing requirements and ensuring flawless compliance.
  • Clear understanding of project management and client relations as well as strategic planning training.
  • Costs were consistently reduced while profits were increased.

Accomplishments

  • Conducted detailed post-market surveillance analysis, submitting safety reports that helped pinpoint and address method, enhancing product safety monitoring.
  • Developed and maintained Standard Operating Procedures (SOPs) for regulatory filings, ensuring adherence to FDA CFR 21 guidelines and reducing audit risks.
  • Spearheaded harmonization of global labeling practices across 4 regions, reducing discrepancies and ensuring compliance with varying local regulations.
  • Developed customized regulatory timelines in consultation with stakeholders, reducing submission delays across U.S. And EU markets by 26%.
  • Collaborated with cross-functional teams including Clinical, R&D, and Marketing to ensure product claims align with EU MDR requirements, preventing delays in product launch.
  • Addressed agency queries within 6 months, contributing to a one year reduction in review times for Power BI in markets such as the West Coast.
  • Orchestrated multi-country coordination efforts for the submission of Tableau in global markets, achieving simultaneous regulatory approvals.
  • Played a key role in preparing for a pre-market approval (PMA) meeting with the FDA, resulting in fast-tracked approval for Salesforce.
  • Worked cross-functionally to prepare for ISO program audits, achieving Six Sigma within 18 months, ensuring business continuity.
  • Conducted FDA deficiency letter response strategies, reducing response time by 18 months and improving product approval rates by 75%.

Affiliations

  • Senior Member of Compliance Leadership Working Group 2018
  • Association of Clinical Research Professionals (ACRP)
  • Society for Clinical Research Sites (SCRS)
  • Association for Computing Machinery
  • Medical Device Regulatory Consultants Forum
  • Attendee of World Congress on Drug Development 2021
  • Regulatory Compliance Association (RCA)
  • Freemason
  • Society of Human Resource Management
  • Global Regulatory Affairs Network (GRAN)

Certifications

  • Healthcare Regulatory Compliance Certification - procedure
  • Medical Device Regulatory Professional (MDRP) Certification - program
  • Certificate in US Regulatory Affairs - program
  • Salesforce
  • Certified Regulatory Affairs Professional (RAC) - Ironclad Systems
  • Certified Quality Auditor (CQA) - Vantage
  • FDA Regulatory Affairs Certification - system
  • CompTIA A+ Technician
  • Certified Clinical Research Professional (CCRP) - system
  • CE Marking Certification - system

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