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 Expert  725331

Expert in Medical Device Regulatory Submissions


Available for your Consulting and Expert Witness Needs

California (CA)
USA
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success.
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510(k) document

Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic and Cosmetic Lasers; Microwave Cardiac Surgery Systems; X-Ray Therapeutic Systems; and Blood Glucose Monitoring Devices.
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ablation

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surgical instrument

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therapeutic device

She is well versed in the Food and Drug Administration's medical device regulation including Current Good Manufacturing Practice and FDA's current Quality System Regulation, as well as Investigational Device Exemption Regulations. She also has extensive experience in foreign device registrations including device testing to standards and electromagnetic compatibility testing.
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Current Good Manufacturing Practice

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electromagnetic compatibility

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FDA medical device regulation

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investigational medical device exemption regulation

Some of the device types she has experience with include Surgical Instrumentation, Electrosurgical Units and accessories, Cardiac Ablation Systems and Catheters;
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cardiac electrophysiology

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electrosurgical instrumentation


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California;  San Francisco, California;  Sacramento, California;  Oakland, California;  Stockton, California;  Fremont, California;  Modesto, California;  Salinas, California;  Santa Rosa, California;  and Hayward, California.

Often requested
with this expert:

Medical Device Regulatory Support, Medical Device...
Implantable and Non-Implantable Medical Device Risk,...
Commercialization of Scientific Devices, Inventions,...
Medical Device Manufacturing & Biocompatible Material:...

Education:
Year   Degree   Subject   Institution  
1997   B.Sc.   Biological Science   University of California, Davis  
1987   AA   Business Administration, accounting emphasis   American River College  

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to

 

(Undisclosed Consulting Company)

 

Regulatory and Quality Consulting

 

Managing Consultant

 

Consulting in Regulatory Affairs and Project Management, including product strategy, global submissions, technical writing, FOIA requests, and product submissions.

2005 to 2006

 

Guidant Cardiac Surgery

 

Regulatory Affairs

 

Senior Associate

 

Evaluate changes to existing products to determine regulatory impact, plan appropriate regulatory strategies, and write regulatory assessments. Support IDE activities for Cardiac Surgery products. Research, write, and file submissions to FDA for product marketing clearance or approval, and negotiate with FDA during product review cycle. Represent Regulatory Affairs on Change Control Board and Product Development Teams. Train, mentor, and supervise other associates (1 direct report).

2004 to 2005

 

TheraSense, Inc./Abbott Diabetes Care

 

Regulatory Affairs

 

Senior Associate

 

Evaluate new products as well as changes to existing products to determine regulatory impact, plan appropriate regulatory strategies, and write corresponding regulatory assessments. Research, write, and file submissions (510(k) and PMA) to appropriate FDA or appropriate regulatory group for product marketing clearance or approval, and negotiate with FDA during product review cycle. Safety Complaint Review and MDR determination. Support international groups with product filings and approvals. Represent Regulatory Affairs on Change Control Board and Product Development Teams. Train and mentor other associates in regulatory requirements.

2003 to 2004

 

Lumenis, Ltd.

 

Regulatory Affairs

 

Senior Associate II

 

Responsible for regulatory activities of Aesthetic Business Unit. Evaluate new products as well as changes to existing products to determine regulatory impact, plan appropriate regulatory strategies, and write corresponding regulatory assessments. Research, write, and file submissions to FDA for product marketing clearance or approval, and negotiate with FDA during product review cycle. Support of international groups for product filings and approvals. Safety complaint evaluation and MDR/Vigilance reporting.

1998 to 2003

 

Boston Scientific Corp./EP Technologies, Inc.

 

Regulatory Affairs

 

Senior Associate

 

Research, write, and file submissions to FDA for product marketing clearance or approval, and negotiate with FDA during product review cycle. Represent Regulatory Affairs on Quality System Review Board, Change Control Board and Product Development Teams. Evaluate new products as well as changes to existing products to determine regulatory impact, plan appropriate regulatory strategies, and write corresponding regulatory assessments. Research Regulations relating to products, and communicate regulatory requirements to other organizational departments. Train and mentor other associates in regulatory requirements.

1998 to 1998

 

Neurex Corporation

 

Quality Assurance

 

Quality Assurance/Regulatory Affairs Documentation Coordinator

 

Designed databases for document & data tracking relating to FDA compliance and company's Quality System. Wrote policy & procedure documents regarding software validation. Set up database for tracking of Adverse Events, and other clinical trial data. Responsible for formatting, editing, and control of QA documents. Maintenance of Company documents and archive for Regulatory Submissions (NDA).

1996 to 1997

 

Applied Imaging Corporation

 


 

Quality Systems Analyst

 

Began tenure in Quality Assurance/Regulatory Affairs as Document Control Clerk, advanced to Systems Analyst - reported to Director of Regulatory Affairs. Acted as Coordinator for Regulatory Submissions. Created database for tracking documents relating to FDA GMP and ISO 9000 compliance, including Quality Manual, DMRs, and DHFs to ensure document files were in compliance. Set up database for regulatory tracking of Customer Complaints and System Performance Reports. Formulated company procedure and policy documents regarding QA Documentation, MIS, and Help Desk. Participated in formation of formal MIS Group. Created, coordinated, and operated Help Desk functions for corporate headquarters. Organized weekly training seminars on computer use. Completed training in technical writing, documentation, Quality Assurance Principles, and ISO Internal Auditor Certification.


Career Accomplishments:
Associations/Societies

Project Management Institute, American Society of Notary Publics, RAPS - RAC Candidate, Healthcare Businesswomen's Association, ASQ. FDLI

Licenses/Certifications

ISO 13485 (2003) Auditor Training. ISO 9000 Documentation and Auditor Training. European Medical Device Regulations (TUV). IIR - Computer and Software Validation. FDA Inspections of Regulated Industry Manufacturers (FDLI). Dale Carnegie Course.

Medical/Professional Internships

Food and Drug Law Internship (FDLI)


Consulting Services:
Recent Client Requests:
  • 510(k) expert for consulting on FDA submission requirments for a surgical laser.
  • Expert for consulting on Review/update FDA listings.
  • Expert for consulting on Surgical laser fiber.
  • Regulatory affairs expert for consulting on diagnostic cardiac catheter (EP).
  • Expert in medical device research and FDA class assessments.
  • Medical device regulatory affairs expert for consulting on PMA filing of a class III medical device.
  • FDA expert for consulting on 510(k) pre-market clearance of spinal column prosthesis.
  • Expert in CE markings for consulting on acquisition of CE marketing for US based foam swab manufacturer.
  • Expert in oral pathology laboratory louisville for consulting on Breast cancer treatment device used in surgery.
  • Expert in quality systems and auditing for FDA regulatory affairs.
  • Expert in orthopedic devices for consulting to sell intellectual property patent.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert for consulting on I-Flow pain pump litigation
  • Pain pump medical device expert witness i-flow for consulting on I- Flow pain pump.
  • Expert for consulting on permissable reuse of catheters in a hospital setting and pricing of new versus reused catheters.
  • Expert witness in FDA investigational medical devices for consulting on pulmonary vein isolation ablation catheters, mapping systems and navigational devices.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Market Research:
20 years Regulatory Affairs experience involving the development of complex and novel medical technologies from concept to product retirement including the following submissions: Contributed to seven PMAs including Modules, Supplements and Annual Reports IDE's (and IDE Reports), Numerous 510(k)'s (traditional, abbreviated, and special), EU Design Dossiers and Technical Files; and Other International Documentation (Asia Pacific and Latin America).

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Provided and delivered training courses on Design Control, Vendor Selection and Management, Quality System Regulations, Risk Management, Regulatory Submissions

Supplier and Vendor Location and Selection

Certified Quality Auditor, have performed supplier audits for contract manufacturing sites world-wide. Have sourced and qualified vendors to ASL/AVL.

Other Skills and Services

Over 10 years experience with cross-functional team environments, roles ranging from support: Cardiac Catheters and Capital Equipment (RF and Ultrasound); including software, Laser Catheters and Capital for Cardiac, Surgical and Aesthetic Use; including software, Surgical Ablation Catheters and Capital Equipment (Microwave) Blood Sugar Monitoring Systems, both meter/strip and continuous; including software Visualization Systems; including capital equipment and software.


 

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