vice president mdic i experienced quality regulatory clinical affairs compliance and operations leader i medical device & life sciences i tplc i project program management i design control i commercialization i qms@ Medical Device Innovation Consortium (MDIC)
Arlington, Virginia, United States
Joseph Sapiente
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FlashIntel GPTJoseph Sapiente is a highly experienced professional with 11.7 years of work experience in the medical device industry. He has a strong background in regulatory operations, FDA regulations, and design control. Joseph has held various leadership positions in reputable companies such as Hologic, Inc. and Medtronic. He is currently the VP of Quality Assurance and Regulatory Affairs at Hologic, Inc. Joseph's expertise lies in FDA regulations, validation, and regulatory compliance. He is based in the United States and has a proven track record in cross-functional team leadership and product launch.
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About
VP Quality Assurance and Regulatory Affairs at Hologic, Inc.
Work Experience
vice president mdic i experienced quality regulatory clinical affairs compliance and operations leader i medical device & life sciences i tplc i project program management i design control i commercialization i qms
Vice President Clinical Science & Technolgy
Associate Vice President, Case for Quality
Medical Equipment Manufacturing
Joseph Sapiente's Professional Milestones
- VP Quality And Regulatory Operations (2015-01-01~2016-10-01): Developed and implemented effective quality and regulatory frameworks to ensure compliance and meet regulatory standards.
- VP Quality And Regulatory Operations (2012-03-01~2015-01-01): Implementing efficient quality and regulatory strategies to optimize operational efficiencies and drive business success.
Skill
Iso 13485
Medical Devices
Regulatory Operations
Fda
Design Control
Cross Functional Team Leadership
V&v
Quality System
Capa
Iso 14971
Validation
Regulatory Affairs
Six Sigma
Product Launch
U.s. Food And Drug Administration
Gmp
Verification And Validation
Corrective And Preventive Action
21 Cfr Part 11
Capital Equipment
Change Control
Commercialization
Root Cause Analysis
Surgical Instruments
Fda Gmp
Biotechnology
Fmea
Quality Auditing
Dmaic
Design Of Experiments
Minitab
Spc
Regulatory Submissions
Biomedical Engineering
Sop
Regulatory Requirements
Standard Operating Procedure
Surgery
Certification
Colleagues
Leah Mcconnell
Director of Communications and Marketing
Carolyn Hiller
Program Director | Clinical Diagnostics
Kara Onorato, MBA
Chief Financial Officer
Jithesh Veetil, PhD
senior program director digital health & technology
Richard Smith
vice president nestcc mdic | health tech executive | entrepreneur | inventor | experienced across tplc | gov | non-profits | corporations | start-ups | funding | r&d | mfg | regulatory | rwe | commercialization | ipos
Other Named Joseph Sapiente
Frequently asked questions
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Joseph Sapiente's social media include: Linkedin,
Joseph Sapiente works for Medical Device Innovation Consortium (MDIC)
Joseph Sapiente's role in Medical Device Innovation Consortium (MDIC) is vice president mdic i experienced quality regulatory clinical affairs compliance and operations leader i medical device & life sciences i tplc i project program management i design control i commercialization i qms
Joseph Sapiente works in the industry of Medical Equipment Manufacturing
Joseph Sapiente's colleagues are Leah Mcconnell,Carolyn Hiller,Kara Onorato, MBA
Joseph Sapiente's latest job experience is vice president mdic i experienced quality regulatory clinical affairs compliance and operations leader i medical device & life sciences i tplc i project program management i design control i commercialization i qms at Medical Device Innovation Consortium (MDIC)
