Greater Philadelphia
Regulatory Affairs Specialist with 4 years of experience in global regulatory operations, international market access, and medical device and IVD compliance at Siemens Healthineers. Proven track record supporting regulatory submissions, UDI data management, and lifecycle management activities across multiple product lines and international markets. Core expertise includes: Global regulatory documentation: preparation of Letters of Intent, submission support packages, and product registration documentation for international markets UDI submissions & IVDR compliance: hands-on experience with IVDR Technical File (TFI) staging and EU regulatory readiness SAP regulatory transactions: product blocking, country shipping restrictions, and compliance-driven release workflows Cross-functional collaboration: partnering with international regulatory teams and logistics stakeholders to drive compliant product releases Lifecycle management: supporting distribution approvals, country requirements management, and regulatory documentation networks across global portfolios Experienced with medical devices, IVDs, and the regulatory frameworks governing them (EU MDR/IVDR, UDI requirements, international distribution compliance). Comfortable managing multiple product lines simultaneously in fast-paced, cross-regional regulatory environments. Currently exploring opportunities in regulatory affairs and related areas within biotechnology and medical devices. Open to connecting with others in the industry.
Supported international product registrations by coordinating with global Siemens RA's/Siemens Departments/OEM's to deliver or generate regulatory/customs documents including, but not limited to, LOE's, studies, IFU's, labels, executive summaries, COA's, etc.
Processes global release and exclusions upon request for 3-6 product lines simultaneously. Provides centralized support to laboratory diagnostics Regulatory Specialists around the world to perform transactions in SAP. Subject matter expert on modifying and submitting Unique Device Identifier data to ensure products are regulatory compliant in the United States. Generates Letters of Intent to provide smooth transport through customs for various shipments.