Curriculum Vitae

Kathleen Johnson, R.N. C.P.

Education

Qualifications

Professional Experience

Professional Memberships

Regulatory Education and Experience

EDUCATION :

1972-1974     R.N. Gwynedd Mercy School of Nursing, Gwynedd Valley, PA

1987-1989     CCP. Clinical Perfusionist, Hershey Medical Center, Hershey PA

QUALIFICATIONS:

10 years experience as a regulatory submissions manager.

CRA training for both pharmaceutical and device studies

 Extensive medical clinical background as Registered Nurse / Perfusionist.

 Excellent working knowledge of medical devices especially in the cardiovascular area.

Ability to direct complex submissions from concept to approval/clearance status.

 Goal-oriented individual with strong leadership capabilities.

 Organized, highly motivated, resourceful and detail oriented problem solver.

 Proven ability to work in unison with team members.

 PROFESSIONAL EXPERIENCE:

 Regulatory Affairs / Clinical Research

2003-Present

Medical Device Approvals, Inc

Fairfield, IA

Executive and Founder: Independent regulatory and clinical research consultant offering:

Regulatory strategy development

Submissions project planning

Clinical study protocol development

Case Report Form development

Monitoring plan review

CRA / Monitoring services  including:

Routine monitoring for post-market approval registry for cardiac re-synchronization device indicated for heart-failure.

Routine monitoring for pre-approval study for cardiac re-synchronization device

Routine monitoring for pre-approval study for deep brain stimulation device.

Routine monitoring for pre-approval study for spinal technology.

1998-2003

Jostra AG                                                                              

Hechingen, Germany

Submissions Manager:

 Developed regulatory strategies, test plans, and compiled submissions for all class II and III products.

Functioned as liaison to FDA and worked closely with R & D engineers and product managers. 

Oversaw submissions from subsidiary regulatory departments.

Established U.S. Regulatory Affairs department.

Defined departmental positions and responsibilities.

Responsible for writing all 510 (K) and IDE submissions

 Submitted 12 class II submissions, 4 class III, in four years.

Developed regulatory strategies for all device submissions to FDA.

Acted as project manager for all U.S. regulatory submissions.

Reviewed protocols of all submission related bench and animal testing.

Key contact for all interaction with FDA including pre-submission meetings.

Identified and provided all standards and guidance documents for device testing.

Evaluated all changes to existing products for regulatory requirements.

Clinical / Management

1989-1998

Medical Center of Delaware                                                                  Newark, DE

Chief Perfusionist: Manager of perfusion services in center performing 1200 open heart cases per year. Reported directly to hospital administration.

1978-1987

Marquette General Hospital                                                                  Marquette, MI

R.N./Charge Nurse/ICU/CCU: Advanced assessment of all types of critically ill medical/surgical patients. Preceptor for new employees.

PROFSSIONAL MEMBERSHIPS :

RAPS – Regulatory Affairs Professional Society

AACP – American Academy of Cardiovascular Perfusion

REGULATORY EDUCATION AND EXPERIENCE:

Regulatory Experience

Submissions:

Submitted multiple 510(K)’s for Class II and III disposable cardiopulmonary products including:

Oxygenators,

Heart-Lung machines,

Centrifugal pumps,

Catheters, Cannula,

Reservoirs and

Custom tubing circuits.

Participated in design, testing aspects and then submitted 510 (K) for “Minimized” perfusion circuit.

Submitted IDE for new procedure/therapy involving long-term respiratory support device with percutaneous catheter access

Clinical Research:

 Developed and submitted clinical study protocol and case report forms involving 40 patients and several centers for a long-term lung support device.

Developed clinical study protocols for device studies including In Vitro diagnostic devices

CRF development

Review monitoring plans

 Contract monitoring services for several Cardiac re-synchronization devices, Deep brain stimulation device and spinal device.

Continuing Education:

Courses:

 CRA Training by Medical Research Management ( 70 hrs. classroom + 2 Wks. “Hands On”)

 Clinical Trials Design

 Good Monitoring Practices

 Investigators Guide to Clinical Research

 Project Management

Seminars:

510(K) Submissions 101

 When to Submit a new 510(K)

 General vs. Specific Labeling

Annual Device Submissions Workshops 2000, 2001,2002

 IDE / PMA Submissions 101