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Susan Keller

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					Yvette Lloyd, Attorney-at-Law                                    Mailing address:
(714) 307-3469                                                   650 N. Rose Drive, #384
yvette.lloydesq@yahoo.com                                        Placentia, CA 92870


EXECUTIVE SUMMARY: Experienced and driven attorney and instructor working in the
healthcare industry both as an attorney and a regulatory affairs advisor. Industry experience
includes working for companies that develop and manufacture drug and device products. Solid
technical and analytical skills acquired as a result of industry experience combined with
educational background in law and science. Industrial experience proffers the ability to connect
between Executive Management and subordinate employees. Accomplishments include:
     Serving as a university instructor while working full-time.
     Facilitating the resolution of 483s and Warning Letters with the Food and Drug
        Administration.
     Facilitating compliance issues with global regulatory authorities
     Serving as an Attorney and a Regulatory Affairs Manager at the local business unit and
        the corporate level due to limited legal and regulatory resources.

EXPERIENCE

2010 – Present Argosy University
University Instructor
    Currently an instructor in the Criminal Justice program.

2010 – Present University of California-Irvine Extension Program
University Instructor
    Currently an instructor in the Environmental Management program

2008 – Present Law Office of Yvette R. Lloyd, Yorba Linda, CA
Owner/Attorney
    Provide legal consulting services for companies engaging in the design, manufacture,
       distributing and servicing of healthcare products.

2008 – Present Beckman Coulter, Inc, Brea, CA
Staff Regulatory Affairs Specialist
     Responsible for global regulatory submissions (510(k), Technical Files international
        dossiers) activities including interface with regulatory agencies.
     Responsible for facilitating post-market compliance of IVD products, including recall
        and MDR/MDV/MPR activities.
     Review and approval of labeling, advertisements and promotional media.
     Interpret and implement new or revised laws into the Quality Management System;
        provide company training as appropriate.
     Assist with personnel training and recruitment

2006 – Present Concord University School of Law
Bar Mentor
     Work with students preparing to take the California Bar Exam. Work includes coaching
       students, root causing study process deficiencies and facilitating corrective action.



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2004 – 2008     Cardinal Health 207, Inc. (Formerly VIASYS Respiratory Care, Inc. and
        SensorMedics Corporation), Yorba Linda, CA
2007 – 2008 Senior Advisor, Regulatory Management (position changed due to restructuring)
    Responsible for global regulatory submissions (510(k)s, Technical Files, international
        dossiers) including interface with regulatory agencies and review of labeling.
    Responsible for facilitating post-market compliance, including recall and
        MDR/MDV/MPR activities.
    Interpret and implement new or revised laws into the Quality Management System;
        provide company training as appropriate.
    Responsible for oversight of quality system compliance, including serving as
        Management Representative, HIPAA Privacy Officer.
    Supervise regulatory affairs and quality assurance personnel.
    Conduct internal audits and manage Internal Audit process.

2005 – 2007 Attorney/Regulatory Affairs Manager (position changed due to restructuring)
    Provide legal expertise for local division and global subsidiaries.
    Interpret and implement new or revised laws into the Quality Management System;
        provide company training as appropriate.
    Conduct due diligence for merger and acquisition activities
    Assisting with discovery activities when dealing with product liability suits
    Review and approve contracts.
    Responsible for global regulatory submissions (510(k)s, PMA Annual Reports, Technical
        Files, international dossiers) including interface with regulatory agencies and review of
        labeling.
    Responsible for facilitating post-market compliance, including recall and
        MDR/MDV/MPR activities.
    Responsible for oversight of quality system compliance, including serving as
        Management Representative, HIPAA Privacy Officer.
    Facilitated company restructuring.
    Supervise regulatory affairs and quality assurance personnel.
    Conduct internal audits and manage Internal Audit process.
    Assist with personnel recruitment

2004 – 2005 Regulatory Affairs Manager
    Supervise regulatory affairs personnel responsible for regulatory submissions, contract
        review, calibration program, post-market surveillance, and failure analysis.
    Responsible for global regulatory submissions activities (510(k)s, PMA Annual reports,
        Technical Files, international dossiers) including interface with regulatory agencies and
        review of labeling.
    Responsible for facilitating post-market compliance, including recall and
        MDR/MDV/MPR activities.
    Responsible for oversight of quality system compliance, including serving as
        Management Representative, HIPAA Privacy Officer.
    Oversight of post-market surveillance programs. Activities include oversight global
        vigilance system, Corrective and Preventive Action Board, and complaint evaluation.
    Assist with personnel recruitment




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2000-2004        Bio-Rad Laboratories, Irvine, CA
Senior Regulatory Affairs Specialist
     Responsible for global regulatory submissions (510(k)s, IDEs, Technical Files, international
        dossiers) of in-vitro diagnostic devices and review of labeling.
     Responsible for facilitating post-market compliance of IVD products, including recall
        and MDR/MDV/MPR activities.
     Responsible for bringing company into compliance with In-Vitro Diagnostic Directive,
        obtaining Quality System certification to new standards through successful Notified Body
        audit, and commencing CE Mark activities.
     Responsible for assisting to bring company into compliance with new Canadian Medical
        Device Regulations and obtaining Quality System certification to new standards through
        successful Notified Body Audit.
     Responsible for bringing company into compliance with Clinical Pathology Accreditation
        Standards and obtaining company accreditation through successful external audit.
     Routine communication and interfacing with domestic and international regulatory agencies
        (e.g., FDA, Notified Body) and OEM customers.
     Lead auditor for internal auditing of company's quality system.

1999 - 2000      Radiance Medical Systems, Inc. Irvine, CA
Regulatory Affairs Analyst
    Responsible for global regulatory submissions (510(k)s, PMAs, Technical Files, international
        dossiers) of Class III and II cardiac devices, and review of all labeling.
    Responsible for facilitating post-market regulatory compliance, including recall and
        MDR/MDV/MPR activities.
    Routine communication and interfacing with domestic and international regulatory agencies
        (FDA, Notified Body) and distributors.
    Responsible for company-wide regulatory compliance to domestic and international
        regulations.
    Set up company-wide compliance training for domestic and international regulations.
    Lead auditor.

1998 - 1999 On Assignment/Lab Support Calabasas, CA
Recruiter
    Responsible for recruitment of temporary science personnel for various industries




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1993 - 1998      Roche Molecular Systems (formerly Boehringer Mannheim, Microgenics
Corporation) Pleasanton, CA
1996 – 1998 Regulatory Affairs Specialist
    Responsible for global regulatory submissions (510(k)s, international submissions) of in-vitro
        diagnostic devices and review of all labeling.
    Routine communication and interfacing with domestic regulatory agencies (FDA, DEA) and
        distributors.
    Provide regulatory expertise to departments within the company.
    Produce labeling for each product.

1993 – 1996 Research Chemist
    Responsible for the basic research phase of Folic Acid assay involving
        Electrochemiluminescent (ECL) technology.
    Scientifically developed, produced, and helped to successfully market three clinically
        diagnostic assays – Digoxin, Vitamin B12, and Folic Acid, using Cloned Enzyme Donor
        Immunoassay (CEDIA) technology.

EDUCATION
   J.D., Honors, Concord University School of Law, Los Angeles, CA
     Deans List all 4 years, Member – Concord University School of Law Honor Society
     Awards: Best Oral Argument, Distinguished Brief

       Graduate studies in Molecular Biology
        California State University, Hayward

       B.S., Biological Sciences, University of California, Irvine, Irvine, CA

PROFESSIONAL AFFILIATIONS
    Member, State Bar of California
    Member, American Bar Association (ABA)
         o Member: Health Law Section, Administrative Law and Regulatory Practice
           Section, Criminal Justice Section, General Practice, Solo and Small Firm
           Division, Legal Education Committee (General Practice, Solo and Small Firm
           Division)
    Member, Orange County Bar Association (OCBA)
         o Member: Product Liability Section, Environmental Law Section, Solo
           Practitioner/Small Firm Section




                                           Page 4 of 5
PUBLICATIONS:
    Calling All Attorneys in Practice Four Years or Less: The Orange County Bar
      Association Wants to Hear From You. (Orange County Lawyer, January 2008 Vol. 50
      No.1., co-authored with Katrina Robson)
    Citizen's Petition, Permit manufacturers to remove intended use statement from box label.
      (http://www.fda.gov/ohrms/dockets/dailys/01/Jun01/061801/cp00001_01.pdf)
    Comments on FDA Docket, 02N-0209: Governing First Amendment Case Law ,
      (http://www.fda.gov/ohrms/dockets/dailys/02/Sep02/091602/80027d3b.pdf)
    Citizen’s Petition to FDA, Use of Symbols for IVD Labeling
      (http://www.fda.gov/ohrms/dockets/dailys/01/Jul01/071001/cp00001_01.pdf,
      http://www.fda.gov/ohrms/dockets/dailys/04/jan04/010704/03D-0383_emc-000003-
      01.doc)

PRESENTATIONS:
    Association of Corporate Counsel (Southern California Chapter) Food, Drug &
     Healthcare MCLE Event (May 12, 2010)
     o Panel member, “Foreign Component Part Suppliers - What Can We Do To Avoid
         Holding the Bag?”
     o Panel member, “We Said That? Navigating the Risks of a Robust Advertising,
         eMarketing & Promotions Program for Medical Products.”
    “FDA Regulations and the impact to Orange County Medical Device Manufacturers”
     (Presentation to the Orange County Medical Device Network, July 15, 2009)
    “Dangerous Documents” (Presentation to the Orange County Regulatory Affairs
     Discussion Group, May 5, 2009, co-authored presentation with Nancy Singer, President
     of Compliance-Alliance, LLC.)

ACTIVITIES:
   Legal Intern, Catholic Charities of Orange County
   National Institute of Trial Lawyers (NITA), Advanced Advocacy, William Mitchell
      College of Law, MN
   Pro bono work in the community
   Volunteer work in the community (Teaching courses at the Catholic Church, teaching
      Junior Achievement program, volunteer with local Boy Scout and sports leagues)

FOREIGN LANGUAGES:
Fluent in Spanish

PROFESSIONAL REFEERENCES:
Provided upon request




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