Amanda Ostrander Email & Phone Number

Mount Juliet, Tennessee, United States

• Directed all aspects of Quality & Regulatory operations for North America including planning, budgeting, staffing, scheduling, monitoring, and reporting. • Mentored and coached staff members; Providing leadership in times of crisis and change initiatives. • Global eQMS implementation from design through launch for 18 sites in 12 countries. • Two facility relocations, integration of three companies (from acquisitions) and two product launches. • Oversaw complaints and reporting to health authorities; assisted Legal on product liability claims.

Nashville Metropolitan Area

• Consulting services on regulatory and commercialization strategies, product submissions, and quality system development. • Project management and implementation services as a MasterControl Partner.

Nashville, Tennessee, United States

REGULATORY STRATEGY - Responsible for the development and implementation of US, EU and China regulatory strategic and tactical planning for on market products and those in development. - Drafted submissions for regulatory agencies, CAP accreditation packages, NYSDOH submissions and assisted with reimbursement dossiers for CMS/MolDx. - Company representative for the Precision Medicine Coalition (PMC) and Association of Medical Diagnostics Manufacturers (AMDM) to collaborate with government officials and partner with industry key opinion leaders on public policy and new legislature. - Introduced Techstreet software for external standard management. CLINICAL RESEARCH - Reviewed research collaboration agreements, study proposals, pharma and assay development services agreements. - Evaluated study designs including participant stratification, inclusion criteria, sample logistics (prospective and biobank samples), and method comparisons to align with clinical claims. - Participated in FDA workshops on Biomarkers, Surrogate Endpoints, Real World Evidence and updates for Clinical Investigators. OTHER PROJECTS - Successfully executed entire laboratory transfer to new ownership including licenses, accreditations, quality system documents and records. - Successfully transferred laboratory test from California to Nashville. - Partnered with R&D and CMO to develop a kitted version of product to decentralize donor derived cfDNA research. - Submitted Breakthrough Device Designation (BDD) request to FDA for assay.

Irvine, California & Nashville, Tn, United States

LEADERSHIP - Worked on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business and regulatory trends. - Exercised judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. - Managed and coordinated the activities of projects with responsibility for results with relationship to cost, methods and employees. COMPLIANCE - Served as company’s Privacy Officer and led compliance activities for company’s Compliance Committee. - Identified gaps in current compliance program and developing roadmap for a more robust compliance program integrated into the company’s other policies and procedures. - Reviewed external facing materials as part of Medical-Legal-Regulatory (MLR) process to assess materials for healthcare compliance and regulatory compliance. REGULATORY AFFAIRS - Responsible for the development and implementation of US, EU and China regulatory strategic and tactical planning for on market products and those in development. - Ensured that regulatory strategies were in line with changing regulatory and business needs. - Served as regulatory liaison and interfaces with notified body, accrediting and licensing bodies. - Advised internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal and Commercial. - Recommended and implemented changes on challenging projects based on knowledge and expertise, accurate interpretation of government regulations, guidances, international standards, as well as corporate policies and management-related considerations. QUALITY ASSURANCE - Responsible for quality program for laboratories in Tennessee, California and Germany. - Served as company’s Quality Manager per the New York State Department of Health requirements.

Irvine, California

QUALITY ASSURANCE - Developed and enhanced the Quality Management System to ensure audit-readiness for US and EU Laboratories. - Oversaw customer complaint determinations, complaint investigations, complaint closures and trend monitoring. - Managed laboratory inspections by state, federal and international agencies (Health Authorities, Notified Body, CAP, NYSDOH) and lead external and internal audits. - Implemented risk management system in accordance with ISO 14971 and IEC 62304. - Implemented and directed quality activities for new product developments and post-transfer changes in adherence with Design Control requirements. - Implemented and directed supplier quality control activities for central laboratory processes and contract manufactured products. - Oversaw Management Review and Quality Metric meetings. - Managed all Quality System Key Performance Indicators (KPI/KQI) and reporting metrics to executive leadership. - Provided guidance to interpret government regulations and certification requirements to assure compliance and conformance (including but not limited to: FDA/QSR 21 CFR 820, 21 CFR Part 11, EN ISO 13485, IVDD / IVDR, MDSAP as well as ANSI, CLSI and other product specific standards). - Fulfilled all Management Representative, Quality and Regulatory Affairs responsibilities during leadership vacancy. REGULATORY AFFAIRS - Identified regulatory requirements for product development and changes to existing products. - Managed labeling for compliance to applicable regulations. Including but not limited to: FDA, EU, CAP, GHS, ECHA and OSHA requirements. - Interpreted regulations and certification requirements for laboratory delivered tests (LDT), medical device / in vitro diagnostic products, and SaMD to ensure compliance and conformance. - Management of accrediting body, state, federal and local licenses and permits for laboratories including: CAP/CLIA, CDPH, NYSDOH, Pennsylvania, Maryland, Rhode Island, Florida, as well as EU Notified Body, LNE GMED).

Irvine, Ca

COMPLIANCE - Ownership of Internal Audits, Management Review, Site Metrics and associated programs. - Assist in management of Non-Conformance/CAPA, Training, and Trending activities. - Participate in external (Health Authority, Notified Body, FDA) and internal audits. - Work with Global Quality System communities to lead improvement and compliance initiatives. - Provide guidance to interpret government regulations and certification requirements to assure compliance and conformance (including but not limited to: FDA/QSR 21 CFR 820, 21 CFR Part 11, EN ISO 13485:2016, MDD, ANVISA, TG(MD)R, MHLW MO169). - Preparation activities for MDSAP, EU-MDR and ISO 14001 recertification. METRICS AND REPORTING - Manage Management Review and Quality Council activities - Manage Quality System and Key Performance Indicator (KQI/KPI) reporting metrics.

Cardiff-By-The-Sea

SOLUTION ARCHITECTURE - Designed solutions for standard practices/ regulatory requirements for automotive, life science and technology companies. - Developed quality system programs with associated metrics to identify positive and negative trends for Product Lifecycle Management, Document Change Control, Training, Supplier Management, Inspection, Nonconformance, Corrective and Preventive Action, Advanced Quality Product Planning (APQP) as well as business and regulatory programs for monitoring regulatory filings and country approvals, onboarding of new personnel and management review processes. SYSTEM IMPLEMENTATION - Developed User and System Requirements specifications and configured software based on current processes and while identifying improvements to increase efficiency. - Conducted conference room pilots, user acceptance testing sessions and GAMP5 validation activities. PROJECT MANAGEMENT - Identified customer requirements through discovery process on projects to establish the key project deliverables and manage changes to the project scope, budget and schedule. - Identified project risks and ensured mitigation throughout the project plan phases. - Partnered with customer project leads, cross-functional groups and other project managers to define/manage resource requirements to support project objectives. - Established and maintained project stakeholder relationships and ensured communication to steering committees. - Created quotes, statement of work contracts and evaluated budget status reports.

Aliso Viejo, California, United States

DOCUMENT CONTROL - Oversaw engineering change order process (ECO, CR, CCB) – ensured all required signatories were accounted for, change requests were processed in a timely manner, released documents and parts, maintained bill of materials and routers. - Maintenance of Standard database (ISO, CFR, ANSI, etc.) and Device Master Record documents. - Led validation of electronic document management & training system for 21 CFR Part 11 compliance. TRAINING - Managed training system – collaboration with Human Resources and Management to determine training plans and training effectiveness measures. - Established training effectiveness programs based on risk and competency. QUALITY ASSURANCE - Leadership and support on all FDA, Notified Body and Internal Audits. - Response to FDA/Health Authority notifications, inquiries and support in recall activities. - Managed Corrective and Preventive Action (CAPA) System. - Handled integration activities after company acquisition. - Oversaw global roll-out of TrackWise software for Deviations, CAPAs and OOS.

Costa Mesa, Ca

ADMINISTRATIVE - Maintained Vendor and Member information in Microsoft Dynamics (CRM). - Organized and maintained hard-copy files. - Sorted large quantities of incoming and outgoing mail. - Various other organizational projects.

Laguna Hills, California

MANAGEMENT - Attended conferences with account executives and coordinators. - Trained and mentored fellow managers. - Maintained schedule to meet customer sales demands. - Maintained Year over Year Growth despite challenging economic environment. - Conducted Inventory demand planning. SALES / CUSTOMER SERVICE - Maintaining customer relationships and loyalty. - Merchandise display and design. - Conducted inventory control procedures.

Laguna Hills, California

Bachelor'S Degree, Psychology

Associate'S Degree, Psychology

Cosmetology License, Cosmetology/Cosmetologist, General