Regulatory Affairs Specialist

Regulatory Affairs Specialist II — Aegis Biopharma Systems

Boston, MA | September 2023 – Present

• Drafted and submitted 5 FDA 510(k) premarket notifications for class II diagnostic devices, securing clearance 18 days ahead of average agency timelines using Veeva Vault RIM.
• Coordinated the transition of 14 legacy product technical files to comply with new EU MDR regulations, utilizing TrackWise to manage document gaps and reduce compliance review cycles by 24%.
• Managed regulatory documentation for 3 successful ISO 13485 external audits, addressing 100% of auditor requests within 24 hours through a redesigned digital repository.
• Reviewed 120+ product packaging layouts and marketing materials annually for FDA compliance, reducing labeling non-conformance feedback loops by 35% using electronic proofing workflows.

Regulatory Affairs Associate — Vertex Therapeutics Solutions

Cambridge, MA | June 2020 – August 2023

• Compiled and formatted 8 electronic Common Technical Document (eCTD) submissions for investigational new drug applications, resolving compilation errors to improve initial acceptance rates by 15%.
• Prepared 45+ post-market surveillance reports and adverse event filings, utilizing LIMS databases to aggregate clinical complaints and submit safety updates 5 days ahead of FDA deadlines.
• Updated 18 regulatory standard operating procedures (SOPs) to align with changing GxP standards, cutting onboarding cycle times for new quality associates by 30%.
• Addressed 30+ official information requests from international regulatory agencies, organizing cross-functional clinical data to decrease median response turnaround times by 40%.

FDA 510(k) submissions, EU MDR compliance, ISO 13485, eCTD formatting, Post-market surveillance, Regulatory strategy, GxP guidelines, Veeva Vault RIM, LIMS, TrackWise, Document Control, Labeling review, Clinical data analysis, FDA Electronic Submission Gateway

EU MDR Transition Initiative

Role: Lead Regulatory Specialist

Tools: TrackWise, Veeva Vault, Microsoft Excel

Managed the gap assessment and remediation of 14 technical files for Class IIa medical devices, achieving full compliance ahead of the EU MDR transition deadline with zero product recalls.

eCTD Digital System Migration

Role: Regulatory Associate

Tools: Veeva Vault RIM, LIMS, FDA ESG

Standardized electronic submission pipelines for 8 investigational drug applications, reducing compilation errors by 50% and improving submission processing speeds by 3 weeks.

• Regulatory Affairs Certification (RAC) - Devices (2023)
• ISO 13485 Lead Auditor Certification (2022)
• Regulatory Affairs Professionals Society (RAPS) Certificate (2021)

• Languages: English (Native), French (Professional Working Proficiency)
• Volunteer Work: Mentored regulatory science graduate students through the RAPS local chapter (2023-present)
• Availability: 3 weeks notice