Profile Details

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Hire Tina O.

United States

USD 100 /hr

Senior-level Regulatory professional with global planning, submission, and quality system expertise

Profile Summary

●Author of 20+ substantially equivalent FDA 510(k) premarket notifications; De Novo and IDE applications, and ROW submissions in over 110 countries for Class IIa/IIb (B/C) and Class III/IV(D)devices, including animal tissue-base devices, software applications, and patient specific devices. ●Manage annual Notified Body audits (ISO 13485; MDSAP, MDR, etc.) with consistently exceptional results. ●Active participant in public consultations and industry groups to help shape future medical device policy. ●Provides Regulatory expertise to exploratory feasibility projects, new product development, and internal/external audit teams. Focus on innovative processes and systems to increase efficiency and improve transparency ●Extensive experience in the development and maintenance of a variety of regulatory policies, processes, and electronic resources (often on a limited budget). ●Active leader/participant in the development, implementation, and maintenance of quality system processes, such as design controls, change control, complaint handling, CAPA as well as systems implementation (ERP, eQMS, etc.). ●Subject-matter expert providing technical support to global users of Regulatory-specific processes,systems, and tools.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Medical Equipment & Supplies
• ☆ Product Compliance
• ☆ Gap Analysis
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing
• ☆ Textbook Content Writing
• ☆ Proofreading & Editing
• ☆ Management Information Systems

Services

• Writing
• Research
• Consulting
• Product Development

Writing Non-Medical Regulatory Writing, General Proofreading & Editing

Research Gap Analysis

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Regulatory Consulting

Product Development Product Compliance , Product Launch Support

Work Experience

Director, Global Regulatory Affairs

Paragon 28 (United States)

- Present

Education

Master of Science - Regulatory Affairs for Drugs, Biologics, and Medical Devices

Northeastern University

August 2011 - May 2013

Certifications

• RCC - EU MDR

  RAPS

  January 2024 - Present

• RAC - US

  RAPS

  January 2005 - Present