Robin F. Martin

About Robin F. Martin

Regulatory Affairs professional with over 12 years of medical device submission experience. Comprehensive understanding of global regulatory landscape and a demonstrated record of over 15 successful FDA submissions, including 510(k)s, PMA supplements and IDEs. Experience in EU MDR and IVDR remediation. Exposure to regulatory and clinical requirements for a diverse array of medical products: injectable implants, combination drug / device product, anesthesia and monitoring equipment, diagnostic imaging systems (MRI, PET/MR & ultrasound), post-processing applications, maternal / infant care products, and medical device software applications.Highly motivated, detail-oriented, strategic thinker with an exceptional track record of aligning and prioritizing tasks to meet business needs.Education: Biomedical Engineering (BS), Master of Business Administration (MBA) Expertise in:• Leading global regulatory and clinical strategy development, as well as pre-submission meeting. • Experience with Good Clinical Practices (GCP)/ ISO 14155 and Quality System Regulations (QSR)/ ISO 13485, MDSAP and EU MDR. • Execution of global premarket registrations (Brazil, Canada, China, European Union, Japan, U.S, etc.) and clinical trial applications. • Review of medical device promotional material for consistency with regulatory filings.• Navigation of changing regulatory environment and effective communication of changing global regulations to development teams.

Experience

1. Co-founder & Chief Regulatory Strategist

   Kinetic Compliance Solutions, Llc

   Apr 2016 — Present

   Obtained 510(k) clearances for ambulatory ECG devices, multi-modality diagnostic imaging feature and dosimetry system. Evaluated regulatory classification and pathways for novel medical devices. Developed and implemented regulatory procedures at mid-size medical device manufacturer. Development of global regulatory strategies and registrations for a variety of medical devices. MDSAP / ISO / Notified Body audit support. Provide guidance on EU MDR / IVDR remediation strategies and develop compliant technical documentation. Successful pre-submission and meeting with FDA. Regulatory services for medical device companies with a specific focus on market access in the U.S, Canada and EU. Partner with a broad range of companies (from emerging to mature) and investors to support regulatory strategies, revenue generation and market access.

Education

• Marquette University

  M.B.A., Business Administration

  2008 — 2011

• Marquette University

  B.S., Biomedical Engineering

  2002 — 2006

Skills

• Validation
• Biomedical Engineering
• R&D
• Sop
• Fda
• Healthcare
• Medical Devices
• Clinical Research
• Capa
• Research and Development (R&D)
• Iso 13485
• Regulatory Requirements
• Medical Imaging
• Regulatory Affairs
• Clinical Trials
• Design Control
• Cross-Functional Team Leadership
• Product Development
• Product Launch
• U.s. Food and Drug Administration (Fda)
• Regulatory Submissions
• Leadership
• Quality System