Jean K. Bigoney Tel. 603-***-****

Quality and Regulatory Affairs - Medical Devices

Summary

Unique skillset offered by career changer from biomedical materials to FDA regulatory affairs. Four successful 510(k)s, Q-Subs for Class I and Class II devices, HCPCS Coding, Detained Entry, Registration and Listing for US and non-US Manufacturers and Importers. SOP Audits. Fluent German.

Technical Expertise

• FDA 510(k) Submissions (Class I and II) • HCPCS Reimbursement Codes

• regulatory pathway assessment • quality management

• biocompatible materials • orthopedic implants

• wound dressings • dental implants and abutments

Education

BS MIT Materials Science and Engineering 9/1978

MS Stanford Materials Science and Engineering 4/1980

PhD Stanford Materials Science and Engineering 3/1983

Professional Experience

5/15- present Senior Engineer - Materials and Process

SNAP-ON POWER TOOLS, MURPHY, NORTH CAROLINA

• Resolve quality issues on manufactured or purchased components

• Act as liaison between engineering and manufacturing, assuring manufacturability of designs

• Improve existing products by recommending design and fabrication changes

• Carry out failure analysis

• Identify opportunities for yield, cost, and quality improvement by eliminating or changing heat treating or finishing operations

• Recommend materials and processes for new product development

• Manage metallurgy laboratory

• Locate qualified suppliers who deliver improved quality product at lower cost

3/14 - Present STURBRIDGE METALLURGICAL SERVICES, INC, STURBRIDGE, MA

Senior Metallurgist

Part-time failure analysis and product development on medical devices and aerospace

3/11-present NU DEVICE CONSULTING LLC, NEWPORT, NH / MURPHY NC

Managing Member

Regulatory and marketing consulting for manufacturers and importers of FDA regulated products (primarily medical devices)

Assessing regulatory pathways for startups, entrepreneurs and potential importers of FDA-regulated products in anesthesiology, general and plastic surgery, and clinical chemistry

Preparing and submitting 510(k)s (K143458)

Auditing 510(k) submissions prepared by clients against FDA RTA criteria

Preparing and submitting Q-subs for medical devices

SOP Auditing / Internal Auditing for compliance to 21 CFR 820

Acting as a US Agent for foreign clients, including advising on compliance to FDA regulations

Submitting HCPCS Level II coding requests and recommendations for reimbursement rates

6/02-6/14 SPRINGFIELD METALLURGICAL SERVICES, INC., SPRINGFIELD, VERMONT

President and Treasurer:

Started new company to perform materials testing, analysis and consulting for local, regional, national and international clients. Medical device regulatory consulting was offered as a sideline.

Three successful 510(k) submissions on behalf of a non-US medical device manufacturer (K063645, K100749, K103176)

Consulting for a European start-up with a novel process to improve biomedical implants

Submitting HCPCS Level II coding requests and recommendations for reimbursement rates

Wrote Technical Manual for a non-US company to fulfill FDA labeling requirements

Translated Quality documents from German to English for a non-US client to fulfill GMP requirements

10/96-03/02 TECHNICAL UNIVERSITY OF MUNICH, GERMANY

Full Professor (Chair for Materials in Mechanical Engineering):

Hired, trained and managed team of PhD scientists, seven graduate students, six interns and nine technicians

Initiated and led ten projects on surface treatment, residual stresses, and biomedical implants

Advised five doctoral students on residual stresses in titanium and high-strength spring steel, electronic packaging, mechanical behavior of notched titanium, aluminum and cast iron, and developing surface treatments for hip-implants.

Developed novel methods to improve surface performance of titanium as a biomedical material

Planned and carried out joint research projects with orthopedic surgeons, maxillofacial, and cardiovascular specialists

Consulted on materials issues with knee implants for medium sized enterprise

Helped launch national research program on the "Interface between Material and Biosystem"

Developed new course on QM including statistical methods, six sigma and kaizen

4/95-9/96 MARTIN-LUTHER-UNIVERSITY HALLE WITTENBERG, GERMANY

Associate Professor (Metallic Materials):

Obtained grants for equipment and personnel

Set up new facilities for heat treatment, metallography, and mechanical testing

Developed and taught courses on materials for electrical engineering, metal working, and physical metallurgy

Acted as liaison between Materials Science Department and Department of Dentistry

Additional Qualifications

Completed course as ISO9001:2000 Internal Auditor in January 2003 (QCS International Ltd)

US Regulatory Affairs Certification (RAC) Regulatory Affairs Professional Society 12/22/2014

International Certified Yellow Belt™ IASSC April 2015

Certified Quality Engineer / American Society for Quality 12/2016

Professional Activities

Member of American Society for Quality

Member of Regulatory Affairs Professional Society

Member of the Titanium Committee of TMS

Member of BMW Scientific Award Jury, 2000-2007

Member of ASM Technical Books Committee, 2004-2007

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