Dylan John

• Investigation of medical complaints and deviations to determine root cause analysis of failures, non-conformities with escape for health risk, perform statistical evaluation, initiate & execute product field actions
• Key Accomplishments:
  ● Execution of Product Field Actions, reconciliation of products from distributors and organizing tracking of devices in the field; Created trackers for Product Field Actions
  ● Adverse Event Reporting in compliance with EUMDR and other regulatory bodies
  ● Organized data from previous Product Field Actions to submit for Audits & CAPA Requests
  ● Connected with other departments (R&D, Manufacturing, Regulatory Affairs, Marketing, Customer services) during lead meetings
  ● Collaborated with BI, data analytics teams on a distributed database project and converted data to compare with GIM. Analyzed production documents, test certificates, reviewed risk assessment files, IFUs.
  ● Coordinated and documented product returns for recalls; Converted and prepared device data & consignee lists utilizing Excel. Performed post market health risk assessment and documented them into Trackwise
  ● Supported Field Actions, Tracked Responses, Follow-up communications to hubs regarding recall notices per FDA

Managed Complaints and Post Market trend data for quality control and continuously improve products to drive the business forward. Participated in regulatory submissions, team meetings, monthly audits, CAPAs, and neuromodulation device trainings.
Reviewed and organized complaints to ensure adequate documentation by following established 21 CFR 803/820, ISO 13485 and ISO 14971, WI, SOP, Preclinical documentation, compliance, quality assurance, and FDA regulatory requirements
Key Accomplishments:
● Evaluated and investigated, identified complaints by gathering sufficient data from 200+ clinical staff, 100+field representatives, 200+internal employees, and laboratory analysis

● Drafted written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers

● Collected, documented, and implemented regulatory reportability decisions using event investigation and regulatory decision models
● Compiled Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities

●Applied Knowledge of EU/medical device labeling, product claims, product lifecycle, product development, QMS

●Provided Companionship and Caregiving to senior citizens and families with everyday tasks
● Assisted senior citizens with a phone conversation and discussed WellCare Health Plan Program
● Helped with medical needs, house tasks, transportation, and supported customers directly

●Programmed and Supported head & voice-controlled VR head-mounted display devices to train on robotic procedures
such as organ biopsies and surgeries
● In charge of day-day operations including lab equipment and medical applications. Inspected, tested, and reported any
non-working devices for repair or instrumentation within a week-to-week deadline.
● Experimented with Medical AR to enable real-time visualization of various tissue types, reducing diagnostic errors by 25% and shortening treatment time by 20%