Profile Details

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Hire Mike K.

United States

USD 150 /hr

FDA Regulatory Consultant

Profile Summary

Mr. Khalil’s professional career spans over thirty (30) years of executive and entrepreneurial leadership in pharmaceutical, medical devices, nutrition supplements, food, beverages, and Tobacco. He has shown leadership skills and gained knowledge in all facets of business management, specializing in manufacturing, product development, quality, regulation. Mr. Khalil has worked for small, mid-size, as well as fortune 500 companies, including Siemens Diagnostics, BIO-RAD Laboratories, Bounty's Nature, and Kerry Ingredients, where he attained in-depth knowledge and expertise in the Food and Drug Administration (FDA) Quality System Regulation (QSR) for medical devices [21 CFR Part 820], dietary supplements [21 CFR Part 111], and food [21 CFR 117]. During his career, Mr. Khalil has assisted numerous small to mid-size organizations in implementing Quality Management Systems (QMS), establishing current Good Manufacturing Practices (cGMP), HACCP hazard analysis, and international standards, including ISO 9001, ISO 13485, and ISO 22000.

Subject Matter Expertise

• ☆ Food Safety
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Risk Management

Services

• Writing
• Consulting
• Product Development

Writing Technical Writing

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Product Validation, Manufacturing, Concept Development, Prototyping

Work Experience

Principal and Senior Consultant

J&J Compliance Consulting Group

July 2018 - Present

Education

Bachelor of chemistry and Biochemistry

Cairo University

September 1984 - May 1987

Certifications

• Certificate in Quality Assurance and Engineering

  California State University

  June 1996 - Present