Medical Device Regulatory Affairs Consultant
Technical Consultant #1656
- 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.
- 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
- 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
- MBA Administration-Operations Management, (With Honors) Regis University, Denver, CO
- B.S. Electrical Engineering Technology, Metropolitan State College, Denver, CO