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Elizabeth P.
Medina, OH
100% Job Success

Q-Metrics, LLC - Consulting for FDA-Regulated Industries

Over 15 years of experience with medical device and pharmaceutical regulatory compliance and quality systems. Areas of expertise include: -21 CFR 820 (Medical Device GMP) -21 CFR 211 (Pharmaceutical cGMP) -21 CFR 111 (Dietary Supplements) -ISO13485: 2016 (Medical Device Quality Systems) -Internal auditing -FDA responses/corrective actions for 483s/Warning Letters -Gap assessment and remediation -Writing and revising policies and procedures for quality system compliance -Regulatory and claim substantiation reviews of labeling and marketing materials -Design control regulatory team member -Risk assessments -Regulatory due-diligence for acquisitions -FDA preparedness training -Supplier management -Complaint management and reporting to regulatory agencies -3rd party audit responses and CAPA development -Recall coordinator -UDI implementation -California Prop65 compliance -State Board of Pharmacy licensure for manufacturers/wholesalers -NAFTA COO Certifications, VA Letters of Supply, Conflict Minerals Surveys, FDA Certificates for Foreign Governments applications -FDA Medical Device Establishment registration and Device Listings -Deviation investigation and risk assessment/mitigation -ABC (American Board for Prosthetics and Orthotics) Facility Accreditation/Medicare Supplier Accreditation (developed quality system to ensure compliance; lead audits) Proficiency in the following: -Trackwise -Salesforce -Word -Excel -Powerpoint -Access -Adobe Specializing in the development of lean, efficient and compliant solutions to address FDA and international regulatory requirements.
Work history
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Skills

Skills

  • Procedure Manual
  • Regulatory Compliance
  • Company Policy
  • Vendor Management
  • Project Risk Management

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