Medical Device Regulatory Expert: FDA Compliance, Validation and 483 and Warning Letter Remediation

Technical Consultant #1675

New medical device product development and transfer to manufacturing.
Compliance consulting to medical device and pharmaceutical clients.
Writing and executing validation documents for new medical device facilities.
Remediation of 483 and warning letters.
Thorough knowledge of FDA regulations with particular expertise in design controls, controlled documentation, validations and change control.
Project management expert.

Undisclosed Company, Senior Consultant, 2001 - Present

Pharmaceutical consultant for clients on remediation of 483 observations.
Prepare response to FDA, including commitment for monthly updates toward final remediation.
Managing client efforts to achieve commitments and submitted monthly updates. Member of four person core team that restructured equipment company's procedures for compliance to QSRs.
Design controls and purchasing controls.
Lead consultant/client team in auditing of numerous DHF and PMA files for FDA compliance.
Coordinating remediation, as required, making recommendations for restructuring design control procedures to streamline development cycle while maintaining QSR compliance.
Writing and executing validation documents for new $150 million device facility.
Develop new structure and procedures for change control and vendor qualification.

Fresenius Medical Care, McAllen, TX /Reynosa, Mexico, Product Engineering Manager, 1993 - 2001

Lead division recovery team that implemented change of all product documentation, a major part of the project that lead to the lifting of FDA import ban on bloodlines.
Facilitated improved communications between plants and division headquarter following lifting of import ban, resulting in improved plant issues.
Coordinated transfer of product engineering from Rockleigh, New Jersey to McAllen, Texas and, thereafter, to Reynosa, Mexico.
Built and managed team responsible for new product development, product improvements, cost reductions and the investigation and resolution of customer complaints.
Developed bloodlines product line to world class standard with leading market share and annual sales of 25 million units, while implementing $6 million in cost reductions.
Managed Product Engineering Laboratory and AutoCAD services.
Provided technical input and responses to FDA for numerous successful 510(k) submissions.

Independent Consultant, 1990 - 1993 and 1984 - 1989

Sheridan Catheter Corporation, Argyle, NY, Senior Project Engineer / Supervisor, 1989 - 1990

Managed the design and development of company and OEM devices.
Supervised project engineers with responsibility for OEM extruded devices.
Developed project plan, including project schedule and capital budget, for tracheotomy tube product line offering significant clinical advantages.

Deknatel (Pfizer), Floral Park, NY, Project Manager, 1981 - 1984

Managed medical device projects utilizing small in-house staff and team of external designers, engineers, and contract manufacturers.
Managed development of a line of surgical skin staplers and extractors, budgeted at over $1 million in development costs.
Managed additional projects in closed wound drainage and chest drainage.
Acted as division internal consultant for plastic and plastic processing.

Bard-Parker (Becton-Dickinson), Lincoln Park, NJ, Senior Project Leader, 1973 - 1980

Within a matrix management organization, managed critical new product development projects resulting in the launch of major product lines.
Managed design and development of pre-filled humidifier and nebulizer product line allowing company to regain leading market share in humidifiers and nebulizers.
Managed development of a line of arterial blood gas sampling kits that attained a 25% market share in an established competitive market.
For pre-fills and blood gas kit product lines, provided engineering support and technical sales training; prepared product graphics, sales aids and promotional materials.
Lead multidisciplinary task force that solved major product failure problem with no interruption in sales.

Credentials

MBA Management, Baruch College, New York, NY

B.S. Chemical Engineering, City College of New York, New York, NY