Jean Asquith - Senior Consultant, Regulatory Affairs

Jean is one of several Emergo consultants with expertise in orthopedic implants and related products. Her expertise in this arena was gained during 15 years with industry leader Zimmer, Inc. She is well experienced in preparing PMA and FDA 510(k) submissions, European CE Technical Files, Canadian MDL submissions, and other regulatory submissions for countries including Japan and Taiwan.

As a trained Biomedical Engineer, Jean brings Emergo clients a deep understanding of implant testing procedures and material biocompatibility issues. She is well versed in FDA, ASTM and ISO procedures and specifications, has written numerous test protocols and is very familiar with finite element analysis.

EXPERIENCE:

Regulatory Affairs Specialist and Research Engineer, Zimmer, Inc. (1989-2004)

• Prepared FDA 510(k) submissions to obtain marketing clearance of new orthopedic devices.
• Wrote and compiled CE Technical Files for implants documenting their conformance to the European Union (Council Directive 93/42/EEC).
• Provided regulatory assessments of new and/or proposed products, detailing regulatory submission requirements necessary to gain PMA or 510(k) clearances.
• Prepared Health Canada Medical Device License (MDL) submissions.
• Assisted with international registration submissions (e.g. Japan, Taiwan).
• Tested orthopedic implants and instruments in accordance with company, FDA, ASTM, and ISO procedures/specifications. Collaborating with Regulatory Affairs and Product Development, designed tests - from conception to completion - that included protocol writing, test preparation, test implementation and report writing.
• Developed and implemented a user-friendly Access Database for 450 technical reports and provided company-wide training on its use.
• Created "Tip Sheets," that summarized tests conducted by the Device Testing Group, for training new employees and employees of other departments.
• Updated departmental procedures to reflect departmental and company changes.
• Reviewed technical reports and advertising materials for regulatory compliance.
• Prepared and wrote Physician Inserts.
• Acted as Team Leader for Device Testing Group. Supervised engineers and technicians.
• Utilized CADKey to design and draw test fixtures and to prepare overall schematics for test protocol, reports, and procedures.
• Developed and wrote standard procedures to help Zimmer, Inc. obtain the ISO 9001/EN 46001 certification.
• Analyzed failed orthopedic implants and instruments to determine mechanisms of failure.
• Assisted Product Development in performing engineering calculations.

Research Assistant, University of Alabama at Birmingham, Dept. of Mechanical Engineering (1987-89)

• Conducted a finite element analysis on an edentulous human mandible.
• Conducted finite element analyses on dental implants.

Test Engineer, Remtech, Inc. (1986-87)

• Tested proposed coatings for the space shuttle solid rocket boosters.

AREAS OF EXPERTISE:

Devices:

• Orthopaedic and dental implants
• Instruments

QA & RA:

• US 510(k) and 513(g) submissions.
• Biocompatibility and materials testing.
• Stress analysis on devices.
  

EDUCATION:

• Bachelor of Science, Mechanical Engineering, University of Alabama.
• Master of Science, Biomedical Engineering, University of Alabama.

HOME BASE:

• Texas USA