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

Technical Consultant #1675


Expertise

  • 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.

Experience

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

  • Conceptual design of internal stapling medical device.
  • Project management of an advanced hearing aid.
  • Development of emergency medicine and surgical devices.

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.

Honors & Publications


Credentials

  • Process Validation Solutions
  • Effective Complaint Handling
  • CAPA Systems
  • FDA Design Control
  • Kepner-Tregoe Problem Solving/Decision Making
  • Customer Relations
  • Human Physiology
  • Plastic Part Design and, Mold Design
  • Advanced Project Management
  • Bioengineering Polymers
  • Value Engineering
  • Medical Packaging and Sterilization
  • Finance for Non-Financial Executives
  • MODAPTS Work Measurement System
  • Fast Track to PRO/Engineer Wildfire.

Education

MBA Management, Baruch College, New York, NY

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

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