Irvine, California, United States
CC Valenzuela, MSc RA
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Ashford University
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FlashIntel GPTCC Valenzuela, MSc RA is a highly experienced Regulatory Affairs and Regulatory Compliance professional with over 23 years of work experience in the medical device industry. She has worked with various types of devices, including cosmetics, neurovascular embolization devices, and neurovascular embolization devices. CC has successfully managed and maintained a Quality System with hands-on experience in supplier quality, internal/external audit programs, and corrective and preventive actions. She is a member of the American Society for Quality (ASQ), Orange County Regulatory Affairs Discussion Group (OCRA), and RAPS.
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About
Regulatory Affairs / Regulatory Compliance / Quality Systems professional with twenty-seven years of experience in the medical device industry. Experience working with devices ranging from Cosmetics to Class III/IV devices (cardiovascular, neurovascular and peripheral vascular). Proven ability to secure approval for a variety of products including, but not limited to, neurovascular embolization devices (coils, stents, flow diverter, liquid embolic, stroke and access/delivery systems) in worldwide markets. (i.e. NA, EMEA, LATAM & APAC). Successfully managed and maintained a Quality System with hands-on experience in supplier quality, internal/external audit programs, non-conforming materials, and corrective and preventive actions, all of which have undergone successful third-party audits with minimal to no observations. Member of American Society for Quality (ASQ), Orange County Regulatory Affairs Discussion Group (OCRA) and Regulatory Affairs Professional Society (RAPS).
...See MoreWork Experience
.
Director, Global Regulatory Affairs
Medical Equipment Manufacturing
CC Valenzuela, MSc RA's Professional Milestones
- Global Regulatory Affairs Manager (2017-04-01~2018-04-01): Developed and executed global regulatory framework, ensuring compliance and minimizing legal risks.
- Director, Global Regulatory Affairs (2018-11-01~): Managing and implementing complex regulatory frameworks to ensure compliance across various countries and territories.
Education
Psychology,
Bachelors,
Bachelor Of Arts
Skill
Iso 13485
Medical Devices
Fda
Capa
Quality System
Design Control
Regulatory Affairs
Iso 14971
Quality Auditing
V&v
Validation
Fmea
Ce Marking
Gmp
Iso
Cross Functional Team Leadership
Regulatory Requirements
Catheters
Cqa
R&d
21 Cfr
Class Iii Medical Devices
Pma
21 Cfr Part 11
Six Sigma
Fda Gmp
Quality Control
Design Of Experiments
Supplier Quality
Regulatory Submissions
Root Cause Analysis
Sop
Biocompatibility
Change Control
Minitab
Medical Device Directive
Software Documentation
Complaint Management
Gxp
Clinical Trials
Dmaic
Sterilization
Glp
Spc
Corrective And Preventive Action
U.s. Food And Drug Administration
Verification And Validation
Certification
Colleagues
David Zivkovic
vice president national sales components oem at asahi intecc usa
Christian Okamoto
Vice President Of Sales Operations
Debra Diener
Vice President Of Sales Operations
James Bucky Polk
Vice President Strategy And Business Development
Yoshi Terai
President | Chief Executive Officer
Other Named CC Valenzuela, MSc RA
Frequently asked questions
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We found 1 CC Valenzuela, MSc RA's phone numbers
CC Valenzuela, MSc RA's social media include: Linkedin,
CC Valenzuela, MSc RA works for Asahi Intecc USA, Inc.
CC Valenzuela, MSc RA's role in Asahi Intecc USA, Inc. is .
CC Valenzuela, MSc RA works in the industry of Medical Equipment Manufacturing
CC Valenzuela, MSc RA's colleagues are David Zivkovic,Christian Okamoto,Debra Diener
CC Valenzuela, MSc RA's latest job experience is . at Asahi Intecc USA, Inc.
CC Valenzuela, MSc RA's latest education in Ashford University
