Stewart Michael Sharp Email & Phone Number

Albany, New York Area

Regulatory Consulting Ltd. provides expert advice to medical device, IVD and pharmaceutical clients on matters related to all aspects of FDA and international regulation, including development of regulatory strategy; preparation, submission and prosecution of regulatory filings; compliance support; quality systems development and management.

Washington, Dc

Senior Consultant with NSF Medical Devices (formerly Becker and Associates) providing compliance consulting for the medical device industry, including Quality Gap Analysis, Quality System remediation, and compliance related to Warning Letters, FD483 responses, etc.,

Directed the regulatory, and medical affairs departments for all of the company's lines of business, both domestic and international

Wilmington, North Carolina Area

Instructor teaching courses in clinical research methods, data management and security, clinical research seminar

Directed all regulatory and clinical efforts for the development of innovative image-based patient specific orthopedic implants.

New Haven, Ct

Established an FDA and ISO 13485 complaint Quality System; Obtained FDA approval for the first fully automated microscopy system for FISH analysis; obtained FDA approval for a variety of cancer and genetic diagnostic tests using rare cell detection technology, including Trisomy 21, bladder cancer, HER2 in breast cancer, etc.

Santa Clara, Ca

Directed all regulatory and clinical research activities in the development of the first FDA approved excimer laser for corneal surgery, including both refractive and therapeutic indications.

New Jersey

Responsible for all Class III medical devices, including the first biologically fixed hip and knee arthroplasty devices.

Phd, Management Science

Diploma, Advance Program For Pharmaceutical Executives

Ma, Organizational Communications

Ba, Natural Science, Philosophy, Communications