Medical Device Regulatory Affairs Consultant

Technical Consultant #1656

Summary

Twenty plus years working in the medical industry in the areas of regulatory affairs, quality assurance, clinical studies, research and development, test, manufacturing and technical service.
Regulatory affairs consultant servicing worldwide providing clients with compliance, submissions and training services to the medical device and IVD Industries.

Regulatory Experience

Expert knowledge of U.S. FDA, Health Canada and the European Medical Devices Directive regulations.
Product approval and clearance submissions such as 510(k)s and PMAs.
Combination device and drug submissions.
Medical device (IDE) clinical trial protocol design, management, analysis and report writing.
Quality system manual and quality system procedure origination.
Design control, CAPA, complaint handling, process control and records development.
FDA 483, warning letter and notified body assessment responses.
FDA QSR and ISO 13485 audits.
Quality system training.
Auditing medical device and pharmaceutical clinical trials.
Import and export issues such as 801(e) and certificates of exportability.
Technical files and CE marking.
Product reports for Radiological Health.
Recalls, safety alerts and physician advisories.

Undisclosed Company, Principal Consultant, 1999 - Present

Writing and submitting 510(k) premarket notifications and premarket.
Applications (PMA's), including for Combination (Device/Drug) Products.
Creating common technical documents.
Designing and managing clinical studies on human subjects.
Conducting assessments of client studies, procedures, and programs to determine compliance to cGMP's, GCP's and GLP's.
Producing Quality Systems Manuals, policies and procedures to comply with worldwide regulations and standards.
Developing and implementing corrective action plans to address deficiencies\in companies' quality systems.
Authoring responses to FDA-483's and warning letters and instituting strategies for bringing companies back into compliance.
Compiling technical files to support the CE marking of products.
Achieving ISO-13485 Registration and CE marking.
Training company employees in all aspects of regulatory affairs and quality systems.

Fischer Imaging Corporation, Denver, CO, Director, Regulatory Affairs & Compliance, 1998 - 1999

Managed corporate regulatory affairs and quality systems to comply with worldwide regulations and standards.
Acted as Quality Management Representative at executive level.
Chaired Corrective Action Board.
Managed design control and technical file teams.
Handled clinical trials and product submissions for government approval and clearance.
Managed FDA inspection and ISO-9001 assessments, along with the responses to deficiencies.
Represented company for the National Electrical Manufacturers Association (NEMA).

GAMBRO Healthcare, Lakewood, CO, 1995 - 1998

Positions: Senior Regulatory Affairs and Quality Systems Development Specialist.

Prepared regulatory strategies, 510(k), IDE submissions and monitored clinical trials.
Developed internal regulatory and quality procedures.
Coordinated FDA inspections and ISO-9001 assessments.
Managed FDA-483 and warning letter responses, along with all corrective actions leading to the clearing of warning letters.
Managed quality systems audit program; provided corporate quality systems training.

Cochlear Corporation, Englewood, CO., Technical Manager, 1990 - 1995

Bard Electro Medical Systems, Englewood, CO., Production Test Manager/Electrical Design Engineer, 1988 - 1989

Academic and Professional Affiliations,

Awards and Honors

MBA Administration-Operations Management, (With Honors) Regis University, Denver, CO
B.S. Electrical Engineering Technology, Metropolitan State College, Denver, CO