1. Joseph A. Ciccone
130 Farnwood Road Mount Laurel, NJ 08054 Email: joenkris06@gmail.com
Mobile: (856) 281.0165
Employment October 2007-Present Church & Dwight Co., Inc.. Princeton, NJ
Senior Manager, Regulatory Affairs
 Organizes and manages the overall project assignments as related to investigational, new, and
marketed products
 Assesses the suitability and adequacy of information and data for its intended purpose of
submission to government agencies or internal documentation
 Prepares or manages the preparation of, and critically reviews, the content and format of internal
documentation and/or submissions [510(k)s] to government agencies
 Provides critical review for regulatory compliance of the content and format of labeling and
promotional materials
 Liaises between Regulatory Affairs and other departments in the company in the preparation of
regulatory documents
 Acts as liaison between Church & Dwight Co., Inc. and government agencies and trade
associations on assigned projects
 Participates in review of consumer complaints to determine reportability of a serious adverse
event, including submission of MDRs, ICSRs, and CPSC complaints
 Provides management assistance to Regulatory Affairs Team
June 2006-September 2007 Inverness Medical, Inc. Freehold, NJ
Quality Assurance Manager
 Applied and managed quality assurance and quality control systems in an FDA regulated facility to
ensure application and practice of Good Manufacturing Practices
 Managed non-conformance, document control, record retention and corrective and preventive
action systems
 Ensured compliance with FDA, ISO 13485:2003 Medical Device Standards and local government
regulations
 Liaised between Inverness-Freehold, NJ facility and Inverness Medical headquarters- Waltham, MA
 Acted as team lead in vendor and government audits
 Wrote and oversaw validation procedures for verification of proper functional and operational
efficiency of newly installed production line equipment
 Wrote, revised and maintained operating procedures for daily production and inspection of raw
materials and finished product
 Responsible for Performing Quality and cGMP training for entire Freehold, NJ facility
 Served as a member on the management review team evaluating and reporting on Quality
Systems and facility controls

2. Joseph A. Ciccone
Page 2
May 2004-June 2006 Musculoskeletal Transplant Foundation Edison, NJ
Regulatory Affairs Associate
 Reviewed and approved labeling, marketing and advertising/promotional materials to ensure
regulatory compliance
 Participated in project development teams, contributing regulatory and submission strategies and
design history dossiers
 Performed internal audits of quality groups for ISO 13485:2003 Gap Analysis, CE compliance, and
compliance with established quality policies
 Assisted in product recalls, Medical Device, Adverse Event and Product Deviation Reporting
 Participated as a team member for development of risk analysis strategies
 Wrote, revised and maintained all required documentation for new and existing product
applications to FDA, Health Canada and other international government agencies
 Maintained government licenses, registration and data reporting to government agencies
June 1998-May 2004 Musculoskeletal Transplant Foundation Edison, NJ
Supervisor of Quality Assurance: Donor Log-in and Receiving
 Facilitated quality assurance of human tissue, finished transplantable materials, and supplies for
the Foundation and transplant community
 Supervised daily functions of Donor Log-in Technicians, Data Coordinators, and Receiving Clerks in
an FDA/AATB (American Association of Tissue Banks) regulated environment
 Ensured compliance with FDA, AATB, ISO 9001, International Standard for Quality Systems and
ISO 13485:1998 Medical Device Standards regulations
 Coordinated inter/intra-departmental training
 Served as a member of the ISO 9001 and ISO 13485:1998 Steering Committee and CAPA
(Corrective and Preventive Action) Team Leader
Education,
Skills,
Commendations
Elizabethtown College; Elizabethtown, PA
 Bachelor of Science in Biology
 11 successful FDA 510(k) submissions in 7 years, 6 personally authored
 Recognized as a leader and placed in leadership development programs
 2010 Recognized Future Leader – Church & Dwight Co., Inc.
 2010 Excellence Award – Church & Dwight Co., Inc., TROJAN Brand Team
 2014 Chairman’s Award Nominee
 High proficiency: MS Windows and MS Office including Word, Excel and PowerPoint
 Excellent skills in navigating highly ambiguous situations
 FRC label review system
 MASTERControl document review system
Societies
 Regulatory Affairs Professional Society