• Responsible for the creation and maintenance of local (US) labeling documents in accordance with Medical Device Core Data Sheet (MDCDS) and the Company Patient Information (CPI), if available, for the company’s device products.• Manages the preparation and compilation of all US labeling documents relevant for registrations and supplements and manages the US implementation process, acting in close collaboration with global and local RA staff.• Contributes to the development of product planning strategies and interacts with product life cycle teams to ensure the timely and accurate implementation of new and revised labeling in accordance with FDA requirements• Responsible for the creation and maintenance of establishment registration information for all US registered device products, oversight of all regulatory related device importation/exportation functions/requirements affecting US bound device products, and coordination and processing of FDA use fees associated with MDUFA.

• External consultant supporting the FDA readiness initiative for the company Quality Transformation Program (QTP)• Performing Gap analysis of processes to include Design Control, Calibration, PM, Non-Conformance/CAPA, Device History Records (DHR), Process Validation, and Product Specifications.• Present results to senior quality management to include remediation strategies.• Lead/Support development and implementation of Flanders site remediation plan.

· Performed regulatory assessments for proposed changes to Verizon Mobile Health Solutions (VMHS) medical devices to determine regulatory submission requirements. Responsible for US FDA pre-market notification (510k) submissions.· Created and implemented all Regulatory processes to support VMHS medical devices.· Regulatory representative for the approval of advertising and promotional materials, clinical article reviews, sales training material, and regulatory review and approval of product labeling and product labeling changes of VMHS medical devices· Managed Complaint Handling Process to ensure compliance to FDA regulations. Responsible for Adverse Event/Reportable Malfunction evaluation and reporting for VMHS medical devices.· Managed Correction and Removal (recall) and Advisory Notice Processes in support of VMHS medical devices.

· Responsible for Regulatory Assessments of engineering changes (ECR) for existing products as well as new product introductions.· Acted as regulatory core team member for high profile company projects. Responsible for the pre-market notification process of medical devices to include submissions of FDA 510(k)s and Canadian License Amendments.· Regulatory approval of advertising and promotional materials, clinical article reviews, sales training material, and regulatory review and approval of product labeling changes.· Regulatory responsibility for the Global Adverse Event/Reportable Malfunction handling process Medical Device and Human Tissue Products.· Managed IDE communications with the FDA. Submitted all reports (Progress Reports, Current List of Investigators, Final Reports, etc…) to the FDA.

· Responsible for the pre-market notification process of medical devices to include submissions of FDA 510(k)s.· Responsible for drug product listings, device listings and FDA facility registrations.· Performed review and approval of Advertising and Promotional materials, and regulatory review and approval of product labeling changes for medical, cosmetic and OTC pharmaceutical products.· Regulatory team member for Product Quality Evaluation (PQE) process. Responsible for supporting decisions for immediate field actions to include product recalls.· Responsible for the Global Adverse Event/Reportable Malfunction handling process for the compliance to applicable Global Regulatory. Led Global Adverse Event/Malfunction Debrief meetings, presenting metrics to senior management.· Led cross-functional Project Team for developing unified MRL review of Advertising and Promotional process during integration of medical device company (Unomedical, Ltd.) into ConvaTec Inc.· Acted as Regulatory representative to the Divisional Change Approval Board (DCAB) to evaluate viability and impact of Change Evaluation Plans (CEPs) from a regulatory perspective. Manage all global regulatory actions for all approved CEPs through implementation/completion.· Project Lead responsible for Development, Implementation, and Maintenance of Global Regulatory Change Evaluation Process to manage coordination of regulatory actions, interdepartmental dependencies (R&D, Change Control, etc…), and release of products for manufacture.· Regulatory Launch Control Protocol coordinator. Sat on the monthly LCP update meetings and assist with any LCPs that required Regulatory input. Worked on team to develop a process to ensure registration completion prior to market release for LCPs worldwide. · Responsible for US regulatory review and approval of Advertising and Promotional materials, and approval of product labeling changes for medical, cosmetic and pharmaceutical products

· Worked in partnership with Region North America (RNA) and our customers to develop and implement quality and regulatory compliance strategies, policies, standards, guidelines, processes and best practices associated with Medical, Beverage, Electronic, Industrial and Specialty gas products.· Responsible for processing of all medical complaints as well as adverse event reporting to FDA where appropriate. Assessed complaint trends and initiated corrective action programs with appropriate departments and personnel.· Led 2-year cross-functional project team to create, implement, and maintain integrated customer complaint process, to include utilization of SAP customer relations module for quick interface by marketing/sales personnel.· ISO Senior Management Representative to ensure ISO compliance. Responsible for quality management system, 2-way communication between leadership and the business, customer satisfaction and continual improvement of the business, senior level reporting, inclusive of BOC liaison with ISO registrar.· Championed leadership activities designed to create RNA business ownership, responsibility and accountability that ensured compliance with Quality regulations and Linde Quality standards· Assisted in the development of quality and regulatory compliance training as needed (including ISO 9001: 2000).· Obtained ISO9001 Certified Auditor/Lead Auditor Training. Led RNA effort in obtaining and sustaining ISO certifications as required· Worked with the RNA Behavioral SHEQ Team to integrate behavioral, quality and regulatory compliance strategies (including ISO 9001: 2000).· Acted as company’s representative on the Compressed Gas Association (CGA) food gases task force. · Ensured compliance to the FDA Bioterrorism Act of 2001 for food gases and products.· Responsible for FDA establishment registrations, device listing, and state level licenses for all medical and food gas facilities.