Vice President Regulatory and Clinical@ Vascudyne Inc
Minneapolis, Minnesota, United States
Mark Stenoien
GET FULL PROFILE 
University of Minnesota
Real-Time AI Research
FlashIntel GPT
Tell me more about Mark Stenoien?
FlashIntel GPTMark Stenoien is a highly experienced professional with over 30 years of strategic and hands-on leadership in key roles in research, development, clinical, quality systems, regulatory affairs, and business management. He specializes in bringing innovative medical devices from concept to commercialization, designing efficient clinical and regulatory pathways, and negotiating effectively with regulators. Mark has a diverse range of business models, including cardiovascular implants, transcatheter therapies, brain injury diagnostics, combination drug-device, biologics, capital electromedical equipment, and disposables. He has held various leadership positions, including Vice President Regulatory & Clinical at Vascudyne Inc and Vice President Regulatory & Quality at OCULOGICA. Mark is based in the United States
For inquiries about Phone Number and Email, please click here Unlock Contact
Emails and Phone Numbers
About
I bring over 30 years of strategic and hands-on leadership, in key roles in research, development, clinical, quality systems, regulatory affairs and business management in start-up through high growth and acquisition. I specialize in bringing innovative medical devices from concept to commercialization, designing efficient clinical and regulatory pathways and negotiating effectively with regulators. I am experienced in a variety of business models including cardiovascular implants, transcatheter therapies, brain injury diagnostics, combination drug-device, biologics, capital electromedical equipment and disposables.
...See MoreWork Experience
Vice President Regulatory and Clinical
Medical Equipment Manufacturing
Mark Stenoien's Professional Milestones
- Manufacturing Technologist (1987-01-01~1989-01-01): Implemented cutting-edge manufacturing processes, optimizing efficiency and reducing costs.
- R And D Engineer (1989-01-01~1992-01-01): Developed and implemented cutting-edge algorithms to streamline processes and enhance data analysis capabilities.
Education
Skill
Fda
Medical Devices
Validation
Clinical Development
Cross Functional Team Leadership
R&d
Regulatory Affairs
Product Development
Quality System
Iso 13485
Commercialization
Biotechnology
Design Control
V&v
Clinical Trials
Design Of Experiments
Ce Marking
Capa
Clinical Research
Verification And Validation
Catheters
Iso 14971
Corrective And Preventive Action
Research And Development
U.s. Food And Drug Administration
Certification
Colleagues
Zeeshan Syedain
Chief Science Officer | Co-Inventor Of Licensed Technology In Regenerative Medicine
Mariah McMahon
director of bioprocessing at vascudyne inc
Richard Murphy
chief operating officer at vascudyne inc
Claus Stoltenborg
chief executive officer at greenland anorthosite mining aps
Zeeshan Syedain
Chief Science Officer | Co-Inventor Of Licensed Technology In Regenerative Medicine
Other Named Mark Stenoien
Frequently asked questions
We found 1 Mark Stenoien's email addresses
Mark Stenoien's social media include: Linkedin,
Mark Stenoien works for Vascudyne Inc
Mark Stenoien's role in Vascudyne Inc is Vice President Regulatory and Clinical
Mark Stenoien works in the industry of Medical Equipment Manufacturing
Mark Stenoien's colleagues are Zeeshan Syedain,Mariah McMahon,Richard Murphy
Mark Stenoien's latest job experience is Vice President Regulatory and Clinical at Vascudyne Inc
Mark Stenoien's latest education in University of Minnesota
