Medical Device Regulatory Affairs Consultant

Technical Consultant #1656


Expertise

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.

Experience

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

  • Managed Technical, Customer Service and Documentation departments.
  • Handled PMA submissions and supplements.
  • Coordinated FDA inspections and FDA-483 responses.
  • Developed company quality system procedures.
  • Assisted with the development of new products and accessories.

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

  • Managed Production Test department.
  • Developed test procedures and fixtures.
  • Designed new products and supported the design of current products.

Honors & Publications

Academic and Professional Affiliations,

  • Regulatory Affairs Professionals Society (Certified).
  • American Society for Quality - Biomedical Division.

Awards and Honors

  • The National Dean's List
  • Tau Alpha Pi National Honor Society
  • Golden Key National Honor Society
  • National Collegiate Engineering Award
  • Academic All-American Collegiate Award
  • Vice-President's Honor Roll - 4 consecutive years
  • Colorado Scholar's Award - 3 consecutive years
  • Regulatory Affairs Certified

Education

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