- 25 years of experience related to medical device manufacture, quality and regulatory compliance.
- Certified Quality Manager, American Association for Quality (ASQ ).
- FDA 510K development and support and managing FDA 510K submissions.
- FDA documentation and FDA warning letters.
- Implementation of ISO 13485 resulting in a systematic quality management system for medical devices.
- IEC60601-1 consulting for basic safety and essential performance of medical electrical devices.
- Past medical devices projects include: Diagnostic systems; Ultrasound; MRI; CT; Defibrillator tester; ECG; Blood and Infusion warmer; IR Thermometer; Electronic Stethoscope; Dental implant and materials; Dicom; RF surgical; Ventilator graphic monitor; and, medical remote alarm.
- Software Test verification and validaton (V&V) for all level of concerns.
- Risk Analysis (ISO 14971) for medical devices.
- Biocompatibility of materials used in medical devices.
- Predicate device analysis.
- Knowledgeable of CRF 21 Part 11 regarding electronic records for medical devices.
Undisclosed Company, Director of Regulatory Affairs, 2004 - Present
- Compliance and regulatory affairs for start up medical device company.
- FDA 510K development including numerous premarket discussions and documentation submissions with FDA.
- Directed clinical study activities.
- ISO 13485 QA system design and implementation.
- Software verification and validation for FDA major level of concern.
Dentatus AB, Quality Manager and Regulatory Affairs Consultant, 2002 - 2004
- Manufacture of dental Implants, dental materials and surgical devices.
- Planned quality audit and corrective action program resulting in changes to factory organization structure.
- Established cross-functional team to prepare SOPs for ISO 9001: 2000 requirements.
- Established first, second and third party auditing procedures.
- Acted on behalf of company during FDA audit to FDA QSR requirements; managed corrective action plan.
- Regulatory projects: Obtained ISO13485 CMDCAS certification leading to Health Canada Certification; Prepared clinical test program and case study to enable long term indication for implants; and, worked with notified bodies to obtain CE marking.
BellSouth Products, Quality Manager and Consultant, 1994 - 1997
- Lead development of quality mission statement, quality policy and to continually communicate this policy to staff and bottom line focused distributors.
- Developed a Supplier Quality Assurance program.
- Analyzed run charts of suppliers to determine statistical state of process.
- Set up a domestic product design arm to create workmanship and design standards and reduce variation within the design of the products.
- Conducted case study of customers leading to user manual revisions and design changes based on customer focus.
- Headed domestic product verification and test group as responsibility was shifted to suppliers.
NATS Corp., Quality Assurance and Regulatory Compliance Consultant, 1990 - 2004
- Project manager and leader for design and manufacturing projects for RF surgical and epilation units.
- Lead QA registrations to ISO 9001: 2000 and ISO 13485, including preliminary and mock audits.
- FDA Marketing clearances, 510K pre-market notification, GMP compliances. Health Canada, CE Marking for medical devices.
Underwriter's Laboratories, Compliance Safety Engineer and Manager, 1979 - 1990
- Quality assurance program implementation.
- Engineering Team Leader: Responsible for compliance team of engineers, assistant engineers, technicians, technical writers and support staff.
Honors & Publications
- ASQ Certified Quality Manager
- American Society of Quality
- Regulatory Affairs Professional Society
- B.S., Electrical Engineering/Biomedical Engineering, Manhattan College, NY