Quality leadership responsibilities expanded to include corporate compliance, ethics and data privacy.· Directed separate teams responsible for employee training, new hire orientation and eQMS and LMS maintenance across multiple quality systems. Developed and maintained all associated procedures.· Mentored and coached quality system directors, managers and supervisors.· Created and maintained business policies and responsible for internal compliance investigations and reporting as Compliance Program Manager.· Effectively responded to complex customer inquiries regarding product data security, GDPR and HIPAA to support Marketing and Sales teams across all business lines as Privacy Officer.· Optimized IT change controls and validation processes to reduce documentation errors and improve validation outputs. · Led computer system validation activities for Salesforce Field Service Lightning implementation and Siebel CRM application upgrade.· Regulatory Affairs department leader for Neometrics (SaaS Data Management for metabolic screening) business line.

Responsible for all aspects of Natus Medical’s eQMS (Agile PLM) and eLearning (eLeaP) platforms across multiple quality systems and countries.· Improved quality system training completion from 50 to 95% for over 1500 worldwide employees and contractors with a team of three employees.· Streamlined Field Corrective Actions, Export Compliance, Internal Quality Audits, Supplier Controls and SCARs by migrating processes to Agile PLM resulting in increased management oversight and employee communication.· Led cross-functional team formed to meet new Board of Directors business policy expectations. Outputs included streamlined Code of Conduct, employee manuals, customer policies and world-wide employee training.· Developed and maintained quality system documentation and computer system validation.· Led computer system validation activities for Oracle EBS application upgrade.· Implemented quality KPIs for Top Management and Board of Directors.

Planned, implemented and maintained all aspects of US FDA, ISO13485 and MDD compliant quality systems while leading international regulatory activities.· Management Representative for San Carlos facility and corporate Quality Management System.· Hosted Notified Body Audits and U.S. FDA inspections for San Carlos and Neometrics facilities, zero audit findings or Form 483 observations. · Migrated Complaint Handling, CAPA, NCR, Adverse Events and International Product Registration processes from paper/shared folders to Agile PLM.· Grew sales by obtaining product registrations in strategic markets: Brazil, China, Mexico and Russia.· Obtained and maintained OFAC licenses for sales of medical devices to Sanctioned Countries.· Designed and implemented new eLearning system (eLeaP) for quality system training, reducing licensing fees by 90%.· Developed and maintained all applicable quality system procedures, work instructions and forms.

Developed and maintained all aspects of multiple US FDA, ISO13485 and MDD compliant quality systems while integrating new acquisitions into Natus quality and regulatory systems.· Consolidated international registration activities across the company and developed new registration process, tracking and management reporting.· Efficiently established a standalone quality management system for Neometrics facility to comply with FDA’s reclassification of Medical Device Data Systems (MDDS) as Class III products. · Hosted Notified Body Audits and U.S. FDA inspections for San Carlos and Neometrics facilities, zero audit findings or Form 483 observations. · Maintained US FDA Establishment Listing for all Natus locations.· Coordinated Form 483 and Warning Letter responses for Natus Seattle and Natus Europe facilities.· Successfully led UDI Implementation Program to meet U.S. FDA UDI deadlines for all Natus products. · Quality Assurance, Regulatory Affairs and R&D Leader for company-wide Oracle Business Enterprise Systems Implementation. Upgraded Agile Advantage to Agile PLM, led Part 11 validation activities for eQMS, ERP and CRM systems.

Planned and executed multi-site quality system while implementing a new eQMS to support product development, document controls and management oversight.· Directed Natus’ FDA, ISO13485 and MDD compliance by developing new corporate quality system to integrate multiple business acquisitions. Outputs included a new Quality Manual, Quality Policy, procedures and work instructions and quality and business metrics.· Successfully modernized Natus’ quality systems into an eQMS as Agile Advantage Project Manager. Led project from requirements definition through implementation, including data migration, ERP integration, validation and training. · Effectively led complaint handling, adverse event reporting, supplier controls, CAPA and NCR Management with limited resources.· Led and executed yearly Internal Audit program and obtained ISO13485 Auditor certification.

Assisted with the development and clinical evaluation of new hearing screening and phototherapy technologies.· Study Monitor for ALGO Datalink, neoBLUE cozy clinical trials and user evaluations. · Regulatory Affairs Product Development Team member for neoBLUE cozy and neoBLUE mini phototherapy devices.· Assembled Design History Files, Technical Files and assisted with 510(k) submissions.· Established Natus Medical Incorporated’s HIPAA Compliance Program and served as HIPAA Compliance Officer.

Assisted with multiple aspects of design, document and quality controls.· Processed Engineering Change Orders on behalf of Marketing, Operations and R&D.· Created and maintained Design History Files (DHF), Device Master Records (DMR) and Technical Files.· Clinical study data entry, record keeping and study monitoring.· Efficiently handled multiple roles including Clinical Studies Associate, Customer Service Representative, Document Control Specialist, Incoming Quality Inspector.