Kimberly McCoy - Senior Consultant, Quality Assurance & Regulatory

As a Senior Consultant for QA and RA, Kimberly has diverse responsibilities. She is actively involved in helping Emergo clients with varied issues including device assessment, classification, labeling reviewing, and analysis of regulatory documentation.

In her years of experience with notable device manufacturers such as Ethicon Endo-Surgery, Johnson & Johnson, Genzyme Biosurgery and Encore Medical, she frequently performed regulatory analyses for devices, compiled Technical Files and Design Dossiers and prepared FDA 510(k), IDE and PMA submissions. Her knowledge of regulatory issues is supplemented by her experience with quality assurance issues related to ISO 13485:2003 and FDA GMP. She puts this extensive knowledge to work for the benefit of Emergo clients worldwide.

EXPERIENCE:

Independent QA/RA Consultant, KJ Consulting, (2006-2007)

• Provided Regulatory expertise and strategies to companies.
• Presented and provided regulatory guidance and solutions on company initiatives to executive management.
• Prepared submissions to the FDA (510(k)s, IDE & PMAs, Annual reports) and international submissions (Canadian Licenses, Technical Files, Design Dossiers, etc)
• Provided training to associates on regulatory requirements.
• Provided guidance to Quality Assurance and Clinical Affairs.

Regulatory Specialist, Encore Medical L.P. (2006)

• Guided design team on regulatory strategy and development projects.
• Present and provide regulatory guidance and solutions on company initiatives to executive management.
• Managed and prepared submissions to the FDA (510(k)s, IDE & PMAs, Annual reports).
• Prepared international submissions (Canadian Licenses, Technical Files, Design Dossiers).
• Provided training to associates on regulatory requirements.
• Provided guidance to Quality Assurance and Clinical Affairs.
• Interfaced with the FDA, Notified Bodies & other international regulatory bodies.
• Managed and prepared Clinical reports for FDA.
• Lead Auditor for Internal Quality System Audits.

Regulatory Affairs Associate, Ethicon Endo-Surgery, Inc. (2002-2005)

• Provided regulatory expertise, made recommendations and gave regulatory direction as an integral member of product development and design change teams.
• Prepared and submitted documents necessary to gain U.S. and foreign regulatory approval/clearance to place new or modified products into commercial distribution - 510(k), Technical File, Design Dossier, etc.
• Lead Liaison with regulatory agencies during audits answering questions regarding regulatory activities.
• Managed and informed Notified Body of quality system and product changes.
• Conducted regulatory activities necessary for the timely preparation, writing and filing of global registrations (Technical Files, Design Dossiers, International filings).
• Participate in activities necessary to assure that product labels and labeling comply with U.S. and foreign government regulations.
• Recommended, reviewed and approved and provided guidance to operations, marketing, product development, package engineering.
• Responsible for regulatory activities for endomechanical products.
• Organized the first Ethicon Endo-Surgery, Inc. International Regulatory Conference focusing on advertising, program content, and entertainment - attended by 21 affiliates from 15 countries

Regulatory Specialist, Genzyme Biosurgery (2000-2002)

• Created, managed and implemented strategies for multiple international regulatory submissions.
• Developed and implemented procedures for international regulatory submissions.
  
• Worked closely with international marketing to meet launch dates and resolve quality/complaint issues with international customers.
• Assisted in complaint handling database and recall activities.

International Regulatory Associate, Johnson & Johnson, Inc. (1999-2000)

• Reduced pre-registration time and technical response time.
• Supported Johnson & Johnson affiliates with technical and registration requests.
• Reviewed Labeling and Advertising Literature for Trademark and Copyright.
• Maintained International Regulatory Database

AREAS OF EXPERTISE:

Medical Devices:

• Endomechanical products
• Orthopedics and implants
• Sutures
• IV Catheters

QA & RA:

• RA-related biocompatibility issues
• Investigational Device Exemptions 9IDE)
• Good Clinical Practice (GCP)
• Technical Files and Design Dossiers
  

CERTIFICATIONS AND TRAINING:

• Regulatory Affairs Professional Society, RAC Certification (US and EU)
• ISO 9001:2000 Lead Auditor training
• Completed Six Sigma Green Belt Training.

EDUCATION:

• Bachelor of Arts in Political Science/International Relations, Texas Christian University.
• Pursuing MBA in Health Care Management, University of Phoenix.

HOME BASE:

• Texas, USA