Description
Summary of Professional Accomplishments and Employment History Sr. Regulatory Specialist InfoSoft (Siemens)-Class II Oct 2015 - present Perform gap analysis and remediation projects outlining deficiencies and/or risks within remediated complaints independently determining and filing appropriate MDRs participating on cross-functional teams providing solutions for compliant closures. * Clear understanding of key medical device regulations such as 21 CFR 820 and ISO 13485 including all aspects of a quality management system. * Review SOPs, CAPAs, complaint system, workflows to identify systemic inefficiencies preventing compliance and closure of backlog. MDR Analyst II US TechSolutions (temp: Halyard Health)-Class I & II Sep 2015 - Oct 2015 Ensured product compliance - and effectively documented, investigated, and implemented corrective actions when warranted. * Evaluated product complaints for FDA, EU, Canadian and other Health Regulatory Authorities as required for reporting requirements * Interfaced with Global Clinical Affairs staff to appropriately execute and classify Vigilance reports Sr. Product Compliance Reviewer Abbott Medical Optics-Class II Oct 2012 - Nov 2014 Audited structures and communicated the value of unfailing complaint data provided Quality System initiatives on product safety ensuring compliance excellence for device/vigilance reporting, SOPs and investigations. Served as Subject Matter Expert (SME) for remediation/GLOBAL regions to adhere regulatory standards and processes identified trends/patterns in quality system data and opportunities for continuous developments. * Corresponded with Product Safety regarding improvements for investigations, thresholds, documentation and analysis of products * Analyzed complaints for product lines, used discretion in escalating unusual product performance issues and insufficiencies regarding adverse reporting, MDRs collaborated with engineers and management to ensure compliance closure of complaints * Provided guidance on FDA and applicable international policies/regulations that affected products, reporting and customers * Demonstrated ability to gather and maintain SharePoint site lists, communicated with site owners and translated business needs into tangible results within SharePoint environment Drug Safety Specialist SRA (temporary) Oct 2009 - Feb 2011 Supported the Vaccine Adverse Event Reporting System (VAERS), a post-marketing safety surveillance program, annotating information about adverse events that occur after the administration of vaccines QA adjudication score averaged 95.5% or above, meeting or surpassing the prerequisite for serious reports on a monthly basis. * Proficient in medical terminology, QA/QC experience of FDA and CDC medically-related data * Documented and offered alternatives for resolving case data quality issues and workflows * Evaluated the accuracy of aggregate adverse event data in support of periodic reporting international and domestic vaccine reports Epic Credentialed Trainer SISTERS OF MERCY (contract) Mar 2009 - Aug 2009 Advised physicians and nurses for clinical end user training of the Epic system perform as a liaison between 62 credentialed trainers and the senior management for scheduling classroom facilitation. * Recommended new product development team efforts and other company objectives as needed to meet deadlines with training information proactively addressed critical questions and concerns by users and trainers QA, Technical Writer KELLY SCIENTIFIC (contract: KV Pharmaceuticals) Jun 2008 - Feb 2009 Participated in investigations for ARISg and product quality complaints to determine the scope, level of concern and corrective action served as the interface between the consumer, medical information group and customer service. * Maintained narrative summaries relating to quality of products and documented adverse events - technical information to aid interactions with customers, author investigation reports, calculate trend analysis and create correspondences to consumers as well as conducted batch and bulk record reviews * Fielded ad hoc requests for data listings from other functions such as clinical, drug safety and medical affairs * Performed product decontamination and assisted engineers with product investigations Proofreader STAFFING SOLUTIONS (temporary: Vandover) Jun 2006 - Dec 2008 Created revisions based on pertinent information provided by job-seeking participants. Worked with consultants, writers as a quality content associate ensuring eminence of product and served as an expert on appropriate formats, content and style. Accomplishments and Employment History Sr. Regulatory Specialist InfoSoft (Siemens)-Class II Oct 2015 - present Perform gap analysis and remediation projects outlining deficiencies and/or risks within remediated complaints independently determining and filing appropriate MDRs participating on cross-functional teams providing solutions for compliant closures. * Clear understanding of key medical device regulations such as 21 CFR 820 and ISO 13485 including all aspects of a quality management system. * Review SOPs, CAPAs, complaint system, workflows to identify systemic inefficiencies preventing compliance and closure of backlog. MDR Analyst II US TechSolutions (temp: Halyard Health)-Class I & II Sep 2015 - Oct 2015 Ensured product compliance - and effectively documented, investigated, and implemented corrective actions when warranted. * Evaluated product complaints for FDA, EU, Canadian and other Health Regulatory Authorities as required for reporting requirements * Interfaced with Global Clinical Affairs staff to appropriately execute and classify Vigilance reports Sr. Product Compliance Reviewer Abbott Medical Optics-Class II Oct 2012 - Nov 2014 Audited structures and communicated the value of unfailing complaint data provided Quality System initiatives on product safety ensuring compliance excellence for device/vigilance reporting, SOPs and investigations. Served as Subject Matter Expert (SME) for remediation/GLOBAL regions to adhere regulatory standards and processes identified trends/patterns in quality system data and opportunities for continuous developments. * Corresponded with Product Safety regarding improvements for investigations, thresholds, documentation and analysis of products * Analyzed complaints for product lines, used discretion in escalating unusual product performance issues and insufficiencies regarding adverse reporting, MDRs collaborated with engineers and management to ensure compliance closure of complaints * Provided guidance on FDA and applicable international policies/regulations that affected products, reporting and customers * Demonstrated ability to gather and maintain SharePoint site lists, communicated with site owners and translated business needs into tangible results within SharePoint environment Drug Safety Specialist SRA (temporary) Oct 2009 - Feb 2011 Supported the Vaccine Adverse Event Reporting System (VAERS), a post-marketing safety surveillance program, annotating information about adverse events that occur after the administration of vaccines QA adjudication score averaged 95.5% or above, meeting or surpassing the prerequisite for serious reports on a monthly basis. * Proficient in medical terminology, QA/QC experience of FDA and CDC medically-related data * Documented and offered alternatives for resolving case data quality issues and workflows * Evaluated the accuracy of aggregate adverse event data in support of periodic reporting international and domestic vaccine reports Epic Credentialed Trainer SISTERS OF MERCY (contract) Mar 2009 - Aug 2009 Advised physicians and nurses for clinical end user training of the Epic system perform as a liaison between 62 credentialed trainers and the senior management for scheduling classroom facilitation. * Recommended new product development team efforts and other company objectives as needed to meet deadlines with training information proactively addressed critical questions and concerns by users and trainers QA, Technical Writer KELLY SCIENTIFIC (contract: KV Pharmaceuticals) Jun 2008 - Feb 2009 Participated in investigations for ARISg and product quality complaints to determine the scope, level of concern and corrective action served as the interface between the consumer, medical information group and customer service. * Maintained narrative summaries relating to quality of products and documented adverse events - technical information to aid interactions with customers, author investigation reports, calculate trend analysis and create correspondences to consumers as well as conducted batch and bulk record reviews * Fielded ad hoc requests for data listings from other functions such as clinical, drug safety and medical affairs * Performed product decontamination and assisted engineers with product investigations Proofreader STAFFING SOLUTIONS (temporary: Vandover) Jun 2006 - Dec 2008 Created revisions based on pertinent information provided by job-seeking participants. Worked with consultants, writers as a quality content associate ensuring eminence of product and served as an expert on appropriate formats, content and style.
Accomplishments
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