Natalie Vollrath

About Natalie Vollrath

Versatile and experienced quality and regulatory professional with 25+ years in the medical device industry. Broad experience implementing, managing, and leading QA/RA strategy and activities towards successful new product introductions in both U.S. and international markets.

Experience

1. Regulatory Affairs Principal

   Radformation

   Nov 2024 — Present

   Develops sound global, regional, and multi-country regulatory strategies for new and modified SaMD medical devices. Provides regulatory intelligence to aid in market assessments and portfolio planning and to monitor impact of changing global regulations on submission strategies & registrations. Prepares international and domestic submissions/registrations to established timelines and company objectives (e.g,510(k), Q-submissions, Technical Documentations), and interacts with regulatory authorities as needed.Coordinates with international contacts on product changes, regulatory notifications and registration/license maintenance. Represents Regulatory Affairs on assigned projects and provide regulatory guidance to the cross-functional teams. Collaborates with cross functional partners in driving and implementing new processes to address non conformances or remediation efforts; authors or revises SOPs to improve regulatory compliance of the Quality System.

Education

• UC San Diego, Extension

  Professional Certificate, Systems Engineering

• UC San Diego, Extension

  Specialized Certificate, Biostatistics

  2011 — 2013

• UC San Diego

  B.A.

Skills

• Quality System
• Fda
• Cqe
• Iso 13485
• Medical Devices
• Quality Assurance
• Regulatory Affairs
• Quality Control
• Fda Gmp
• Manufacturing
• Cqa
• Product Development
• Capa
• Design Control
• Validation
• Quality Auditing
• Gmp
• Change Control
• Quality Management
• Iso
• Process Improvement
• Business Process Improvement