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Hire Denise A.

United States

Medical Device Global Quality and Regulatory Expert

Profile Summary

I am an experienced Quality and Regulatory professional with over 25 years in the medical device manufacturing industry. I have worked with Class I, II and III medical devices where I have developed implemented and managed Quality Systems as required by domestic and international regulations, such as, but not limited to FDA, ISO, European Union, Therapeutic Goods Australia and Health Canada. I am a trained ISO 13485 Lead Auditor/Auditor. I have over 20 years of experience working closely with domestic and international regulatory agencies, competent authorities and notified bodies. I have experience in drafting and maintaining Design History Files and technical files. I also have experience with drafting and submitting PMAs, 510(k)s, technical dossiers and other regulatory submissions and responses.

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ☆ Biomedical Engineering
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Implants
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Healthcare Quality Improvement
• ☆ Regulatory Affairs
• ☆ Medical Equipment & Supplies
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Formulation, Product Evaluation, Concept Development

Work Experience

QA/RA Officer

D & M Global Consulting

September 2015 - Present

Director of Quality Assurance and Regulatory Affairs

Professional Resource Partners

May 2019 - June 2020

Sr. QA/RA Specialist

Nipro Medical Corporation

September 2015 - May 2019

Education

Bachelor's of Science and Associates of Business Administration

American Intercontinental University

January 2003 - April 2008

Associate of Arts (Paralegal)

Collin County College

March 2000 - June 2002

Certifications

• Certification details not provided.