Amanda Deraad

Background

About Amanda Deraad

Certified Project Management Professional (PMP) • Certified Six Sigma Green Belt (CSSGB) • 13+ years Program and Project Management • 10+ years People Management • 13+ years in Life Sciences Industry • 13+ years cGMP, ISO, FDA, and EU Regulated Environment Experience • Army Veteran Current Projects-Establishment of a Program Management Office in Regulatory Affairs as the central center of organizational project knowledge, with expertise-related project management practices, techniques, and standards-Change Management Process Improvement: Governance, escalation pathways, communication, and cross-functional awareness to ensure product changes are handled in a consistent manner-Global Labeling: Ownership of regulatory activities for several large scale labeling changes impacting >600 products registered in ~85 countries. Recent Projects-Quality and Regulatory Integration: Integration of recent acquisition's quality operations, regulatory certifications and Quality Management System into our own, including gap assessment and remediation of non-harmonized processes and procedures per FDA 21 CFR Part 820 and ISO 13485-Continuous improvement projects utilizing Lean Six Sigma methodology for quality operations, regulatory and quality systems-Quality and Regulatory Program Management: Support for drug/device combination products and customer in the areas of quality improvement, change management, regulatory submissions, regulatory compliance, SCAR and CAPA ownership-Notified Body Transfer: Transition and consolidation of notified bodies for ISO 13485:2016, ISO 9001, EU Annex II and EU Annex V. Involved quality system and technical file audit preparation, response drafting and corrective action implementation- EU Medical Device Regulation (EU 2017/745): Review of all products in portfolio to meet upcoming EU MDR requirements. Included development of a reverse engineering remediation process to ensure documentation is state of the art for identified products. Areas of remediation comprised risk management (per ISO 14971), clinical evaluation, design controls (including FDA 21 CFR 820), Design History File assembly and remediation (per FDA 21 CFR 820), labeling, design verification and validation, biocompatibility (per ISO 10993), packaging validation, regulatory and post market surveillance. Led five cross functional teams through the remediation process for Class IIa and IIb devices (hardware and disposables).