Manager Quality
Resume:
Cynthia D. Oris, RAC
**** ******* **** * ******, Ohio 44121
Ph: 847-***-****
Email: abmbrh@r.postjobfree.com
SUMMARY
A successful Regulatory Affairs and Quality Systems professional possessing a strong record of achievement
combining regulatory/quality skills and strategy in diverse areas of medical device and pharmaceutical
development. Highly motivated and capable of working with a diverse group of individuals to obtain a
positive work environment.
MAJOR CAREER RESPONSIBILITIES:
• •
Participates in all relevant company Maintains an effective quality system in
leadership activities as the regulatory accordance with the appropriate regulations.
•
representative Management of quality system processes, i.e.
• Direct interface with FDA, DEA, Notified complaint processes, adverse event reporting, CAPA
•
Body and international regulatory agencies Incorporating regulatory strategies to obtain
• Maintains a current knowledge ISO 13485, MDD, domestic/global product approval on all initial
CMDCAS requirements submissions
• Quality Manual and Operational Procedures
(SOP) development
CAREER HISTORY
BISCO, Incorporated, Schaumburg, IL 2008–2010
2000-2001
Manager, Regulatory Affairs- Dental Restorative Materials, Polymerization Equipment
• Provide Regulatory Affairs support to cross-functional departments to manage product
development/post surveillance projects.
• Prepare regulatory documents to include 510(k), EU Technical File, DOC and global annual
registration requirements.
• Manages labeling/IFUs for content and format, including authoring product MSDS.
• Maintains product complaint process, adverse event reporting, investigations, CAPA
• Maintains OEM/Contract Manufacturer customer activities
• Internal Quality Systems Auditor facilitator
• Initiator/Manager of Firm-Initiated Recall, Correction and Removals and Advisory Notices
• Hosted FDA/Notified Body facility inspection, to include follow-up corrective action
• Prepared regulatory and quality training for company wide personnel.
• Prepare, review and approve policies and procedures (i.e. Labeling, Complaint, Adverse
Event/Incident
CIBA Vision Corporation, Atlanta, GA 2005-2007
Sterile Contact Lens, Contact Lens Care and IOL Manufacturer
Independent Contractor assisting in multiple US and global projects for GRA/GQS Departments.
• Maintained product complaint process, adverse event reporting, investigations, CAPA
• Lead efforts to improve the complaint processes/systems utilized by the Global Quality Systems
Department.
• Representative for the global training and coaching of all diverse users of GCMS (Global Complaint
Management System)
• Preparation of Supplements and PMA annual reports
Page 1 of 3
Cynthia D. Oris, RAC
4506 College Road S Euclid, Ohio 44121
Ph: 847-***-****
Email: abmbrh@r.postjobfree.com
CAREER HISTORY, continued
GF Health Products Inc., Atlanta, GA 2003-2005
Manager, Regulatory Affairs-DME/ Prescription Device/ Pharmaceutical Manufacturer
• Facility representative for the management of compliance activities for FDA Regulatory requirements
• Manages labeling/IFUs for content and format, including authoring product MSDS
• Foreign/Domestic Initial/Annual Registrations and Device Listings (US Agent)
• Maintained state licenses for prescription devices/pharmaceuticals
• Hosted FDA facility inspection, to include follow-up corrective action
SIEMENS MEDICAL SYSTEMS INC., Hoffman Estates, IL 1994 -1997
1999 -2000
Senior Compliance Specialist, Nuclear Medicine Group
• Maintained product complaint process, investigations, and adverse event reporting
• Served as Chairman of the Complaint Review Board, comprising 15 members
• Oversaw all Adverse Event Reporting, including Advisory Letters/Recalls
• Implemented a complaint database
TEXTILEASE MEDIQUE Products, Skokie, IL 1997-1999
Manager, Regulatory Affairs/Quality Assurance Department- OTC/Prescription Pharmaceuticals
• Hosted FDA facility inspection, to include follow-up corrective action
• Develop label copy, both text and design, for all printed labels and labeling, MSDS
• Responsible person for RA review and approval, including revisions for all printed materials
• Directed the supplier pre-press activities
• Maintained product complaint process, investigations, and initiated corrective action
• Assured compliance with FDA monographs and foreign regulations
• Managed and operated the Stability Program/Retention and NDC files
EDUCATION/CERTIFICATION
Case Western Reserve University /University Hospitals of Cleveland, Cleveland, OH
American Radiology of Radiologic Technology
Regulatory Affairs Certification (RAC US)
Professional Training: Quality Systems Regulation, Complaint Handling/Post Market Surveillance
Program, MDR Regulations, Corrective and Preventative Action (CAPA), Design Control, FDA Inspections
(QSIT), FDA Enforcement, ISO Quality Systems/13485, Medical Device Directives, CE Marking
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Cynthia D. Oris, RAC
4506 College Road S Euclid, Ohio 44121
Ph: 847-***-****
Email: abmbrh@r.postjobfree.com
REFERENCES FURNISHED UPON REQUEST
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