Jacqueline A. McCulloch

• Senior Medical Writing Consultant with focus in areas of experience including regulatory, compliance, quality systems, scientific publications, and clinical writing
• Industry experience includes medical devices, IVDs, biotech

• Provided Regulatory Affairs medical/regulatory submission writing support to R&D-chronic care products
• Supported marketing with product claims and advertising/promotion review/support for regulatory responsible products

• Managed Regulatory Affairs Strategic Programs Governance Program to streamline regulatory affairs operations for (13) projects in the Patient Monitoring Operational Unit and provided regulatory writing support for (3) 510(k)s
• Provided regulatory support to Operational Excellence (Op/Ex) project teams for design modifications to currently marketed medical devices for (18) projects

• Provided regulatory writing support for several FDA submissions, (2) EU MDR/IVDR transition projects (technical documentation/PER/CER), and led expansion of a regulatory operations function for an IVD manufacturer
• Managed staff of (5) personnel in Medical Writing, Global Regulatory, and Quality Systems function

• Provided medical/regulatory writing support to SMEs and managed (5) modular PMA infectious disease molecular biological IVD assay submission software modules to FDA and Health Canada for submissions required to support medical devices throughout product lifecycle (i.e., annual reports and supplements)
• Developed and maintained product (2) regulatory strategies

• (Managed all regulatory submissions, including medical/regulatory writing, for (2) combination product drug delivery systems
• Acted as liaison to Medical Device notified body DEKRA to obtain CE Mark CoC for a combination device
• Developed and maintained combination product regulatory strategy

• Conducted remediation activities for various consulting firms to address client warning letters, consent decrees, and corporate integrity agreements
• Authored quality and complaint investigations (medical/regulatory writing)
• Conducted thirty-seven (37) class III implantable medical device complaint investigations, twenty-three (23) parenteral product complaint investigations and forty-two (42) quality investigations
• Led audit team for forty (40) pharmaceutical product data integrity audits under FDA third party review

• Managed Regulatory Affairs and Regulatory Compliance staff of nine (9) associates
• Served as management representative for three (3) sites and managed FDA and Notified Body inspections

• Developed and managed a new quality system for Roche Diagnostic insulin pump business acquisition including implementation into Master Control Document Control, Training and Quality System in (3) months
• Remediated all labeling to ThermoFisher Scientific brand

• Coordinated clinical study data publication strategy and developed (2) scientific posters plus (3) manuscripts for physician review

• Authored IFUs, traditional/abbreviated 510(k)s, MDD technical files and design dossiers
• Developed and managed processes for approval of advertising and promotional materials including claims support
• Managed clinical and outcomes studies for device indication expansion and claim support
• Authored manuscripts and posters

• Authored (5) final clinical study reports for Actonel phase II clinical study data to support FDA submission.