RAQA Expert

RA/QA Expert with 20+ years of devices, IVD and pharmaceuticals, with experience across life sciences environments and cross-functional leadership across Quality, Regulatory, Manufacturing and Clinical

Experienced in MDD to MDR transition, EU MDR 2017/745 remediation, IVDR compliance, CE marking, UKCA marking, Technical Documentation, Notified Body interactions, and global regulatory submissions and market access

Strong in ISO 13485 and ISO 9001 QMS management, FDA QSR/QMSR Compliance, CAPA, risk management (ISO 14971), change management, audit and inspection readiness and continuous improvement across regulated environments

Supported product lifecycle management, compliance and certification readiness

Drove MDD to MDR transition and EU MDR 2017/745 remediation as a core project team member for Class devices, supporting CE marking, Notified and regulatory compliance

Served as Quality Approver for Technical SOPs, and change controls, ensuring requirements

Provided regulatory and quality guidance management (ISO 14971), PMS

Strengthened ISO 13485 QMS processes

Partnered with Regulatory, Quality, regulatory compliance and effective execution across activities

Led Technical Documentation ownership for Technical File readiness

Owned regulatory strategy to drive IVDR

Contributed to CER development

Supported ISO 13485 QMS alignment with compliance, audit readiness

Collaborated with cross-functional teams Commercial functions to align development

Led EU MDR 2017/745 transition and remediation, regulatory submissions, and product lifecycle management

Owned regulatory strategy and provided cross-functional Regulatory Affairs and Quality leadership for Class Ila Software as a Medical Device (SaMD), ensuring compliance with EU MDR 2017/745

Owned Technical Documentation, including GSPR, CER, PMS, PMCF, PSUR, vigilance, risk management (ISO 14971), and Technical File readiness, leading CE marking activities and Notified Body interactions

Managed ISO 13485 QMS alignment with EU MDR requirements, including CAPA, change control and continuous improvement initiatives

Led Notified Body audit preparation, resulting in successful ISO 13485 recertification, and ensured FDA inspection readiness

Led Notified Body audit preparation, including ISO 13485 and ISO 9001, across medical device and pharmaceutical environments, ensuring audit and inspection readiness

Strengthened ISO 13485 and ISO 9001-control, documentation accuracy, and compliance

Supported MAA submission for veterinary, including Module 3 CMC quality documentation

Oversaw supplier qualification, supplier, with quality and regulatory requirements

Led CAPA and nonconformance

Led preparation for Notified Body audits, including ISO readiness and regulatory compliance for Class Ila medical

Contributed to EU MDR remediation strategy and implementation, strengthening regulatory compliance and aligning ISO 13485 QMS processes with MDR requirements

Supported FDA 510(k) submission activities for Class II risk management (ISO 14971), design controls

Collaborated with Regulatory, Quality, R&D, Manufacturing, and teams to support product lifecycle management, regulatory compliance

Supported Notified Body and FDA inspection readiness product environments, aligned with ISO 13485, GMP, GDP

Developed and implemented GMP-compliant, strengthening, traceability and audit readiness

Oversaw engineering change control (ECC), CAPA, traceability and data integrity

Supervised GMP service contractors and collaborated to support operations and lifecycle activities