Responsibilities include, but are not limited to:Manage FDA, EU product listings / submissionsManage international product registrations in coordination with CEO and SalesServe as the Official Correspondent between FDA and our organizationServe as the project lead for the UDI implementation and executionServe as the the System Administrator for our QMS Software and implement key modules within the system company wideServe as the Document Control Administrator, QT9 QMS SMEServe as the Training AdministratorServe as the CAPA and Internal Auditor CoordinatorEstablish the Label Review Committee - create procedures, provide training, lead weekly meetingsPerform market research as necessaryComplete gap analysis regularly to ensure metrics are being metTracking of KPIs monthlyServe as lead for RA action itemsProvide any/all training associated with updated/new standards/regulations pertaining to QMS, medical devices, etc.Participate in all audits, specifically FDA, ISO, IntertekR&D Project Team Member, providing regulatory guidance on all new product development projectsCreate and maintain annual training pertaining to cGMP, FDA Medical Devices, Canadian Regulations for Medical Devices, updates regarding the European Council MDD 93/42/EEC and EU MDR, in addition to many other major markets.Create, maintain, and update all technical files for EU marketed medical devicesPrepare the required product submissions per country requirementsComplete annual establishment registrations and product license renewals.Provide RA budget to Director of Quality annuallyEstablish and execute projects that drive completion of organizational goals.

Acquire, prioritize, and complete all International product registration requests for the Preventative SBUAnalyze several key metrics and develop continuous improvement plans for the registration process.Coordinate with our Corporate Division in updating and maintaining our Regulatory Status of Marketed Products (RSMP) as well as Canadian medical device licensing.Complete new product submission for the EU, Health Canada, Japan, Australia, Brazil, and Rest of World as directed per the regulatory requirements specific to the product.Provide regulatory expertise for new product projects.Coordinate with the Research and Development department by providing standards and regulations for new products.Successfully create and update technical files, NAFTA certificates, CoC's, NDC Forms, and other documentation.Perform periodic review of divisional documents.Create and execute CE Mark pathways for new products.Participate in internal audits as well as addutuonal regulatory audits such as BSI Quality Management Review Audits, FDA inspections, etc.Provide expertise weekly in Label Review Committee meetings in order to help maintain regulatory compliance of our labels and other marketing material.Draft and maintain distributor agreements.Ensure all state licenses are current.Proactively engage in educational opportunities to gain knowledge in the most current regulatory requirements for all regulatory authorities globally.

Serve as our facility’s compliance coordinator as well as process improvement coordinator.Update processes based on data obtained and compared against various metrics.Participate in facility audits, safety committee meetings, debriefing, and corrective action planning.Ensure facility issues are resolved within a 30 day period with complete documentation of the progress.Analyze a wide variety of data in order to propose continuous improvement strategies amongst other key reports to the Facility Manager as well as Regional Facility Manager.Execute projects tasked by the Regional Manager in a timely manner effectively.Create and maintain several key logs and databases for our facility that provides a breakdown of our goals, metrics, and actuals.Serve as a back up to the Office Supervisor in her absence.Provide excellent customer service in regards to scheduling, questions on orders, as well as complaints.

Successfully completed 510(k) product submittals as well as product registration requests from our international customers while following the FDA Medical Device Registration regulations/guidelines, ISO 13485 guidelines, as well as specific European regulatory body regulations.Orchestrated customer product returns and customer complaints efficiently as well as maintained the database for returns and complaints.Participated in quality, customer, and internal audits alongside the Director of Quality/Regulatory Affairs.Used due diligence in regards to keeping updated on all informative materials specific to medical device regulations.Presented reports in a weekly meeting with our engineering and marketing teams to maximize product sales as well as product improvements.Managed all licenses renewals for the company.