Wenda Carlyle
University of Minnesota
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Wenda Carlyle is a highly experienced professional with 26.8 years of work experience in the medical devices industry. She has a strong background in start-ups, FDA regulations, biotechnology, and new business development. Currently, she is the Chief Scientific Officer at Nectero Medical, Inc., where she provides expanded regulatory advice to her clients. With a focus on FDA preclinical and IDE submissions, Wenda has successfully managed a drug-eluting stent program and contributed to various projects in the field. She has also held leadership positions at Mandrake, Edwards Lifesciences, Medtronic, and GE Healthcare.
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About
Beginning in 2017, I have merged my consulting company with CardioMed Device Consultants. While continuing to consult on a wide variety of technical areas, the partnership with CardioMed allows me to provide much expanded regulatory advice to my clients. I have gained considerable experience in FDA preclinical and IDE submissions and enjoy working within a framework of colleagues with specific expertise in all different aspects of the regulatory process. Recent accomplishments include project management of a novel drug-eluting stent program from pilot studies to IDE submission as well as contributing to the program support of a number of additional projects including cell-based therapy, biopharmaceutical drug products, and a wide variety of intravascular medical devices.
...See MoreWork Experience
Chief Scientific Officer
Medical Equipment Manufacturing
Wenda Carlyle's Professional Milestones
- Director Controlled Release Technologies (2000-01-01~2002-01-01): Developing and implementing cutting-edge controlled release technologies to optimize the company's digital assets.
- Principal Scientist (1997-01-01~2000-01-01): Inspiring and leading a team of scientists to lead groundbreaking research projects.
Education
Pharmacology,
Biochemistry
1985-1991Skill
Medical Devices
Start Ups
Fda
Biotechnology
New Business Development
Strategic Planning
Healthcare
Management
Strategy
Business Development
Leadership
Project Management
Lifesciences
Business Strategy
Marketing Strategy
Software Documentation
Process Improvement
Change Management
Certification
Colleagues
Alex Schwarz
Vice President CMC
Kelvin Ning
svp technology at nectero medical inc
Anil Dasu
Chief Engineering Officer
Amy Blawas, Ph.D., R.A.C.
Vice President Regulatory Affairs
Kim Williams
Vice President Of Operations
Other Named Wenda Carlyle
Frequently asked questions
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Wenda Carlyle's social media include: Linkedin,
Wenda Carlyle works for Nectero Medical, Inc.
Wenda Carlyle's role in Nectero Medical, Inc. is Chief Scientific Officer
Wenda Carlyle works in the industry of Medical Equipment Manufacturing
Wenda Carlyle's colleagues are Alex Schwarz,Kelvin Ning,Anil Dasu
Wenda Carlyle's latest job experience is Chief Scientific Officer at Nectero Medical, Inc.
Wenda Carlyle's latest education in University of Minnesota