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Michael Husband, Pmp is listed as Senior Director, Medical Devices and Combination Products at Voisin Consulting Life Sciences (VCLS), a company with 178 employees, based in Bridgeton, New Jersey, United States. AeroLeads shows a work email signal at voisinconsulting.com and a matched LinkedIn profile for Michael Husband, Pmp.
Michael Husband, Pmp previously worked as Senior Lead Consultant at Eaglelon Consulting and Director, Office of Regulated Activities at Us Army Medical Research And Materiel Command (Usamrmc). Michael Husband, Pmp holds Master Of Science - Ms, Applied Biomedical Engineering from The Johns Hopkins University.
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I am proud to have played my role in many amazing advances in healthcare diagnosis, delivery methods and treatments throughout my 20-year career. Whether as a clinical engineer seeking new methods of breast cancer treatment or as a product and program manager overseeing blood-based diagnostic assay for Traumatic Brain Injury detection, I have helped integrate many important innovations into our healthcare system.I am a strategic planner and analytical thinker who is skilled in predictive modeling and metrics analysis. I understand the entire research, testing and commercialization process of biomedical research. In addition, I have an understanding of the laws, regulations and guidance (21 CFR) necessary to gain FDA approval. When you bring these skills together, you have someone who can create and execute an actionable regulatory approval strategy for your concepts, products and technology. I enjoy translating medical concepts from the early research phase into production and marketing. As an engineer, I can speak the language of the researcher and developer. However I can also interact effectively with key stakeholders, leaders and regulatory officials to clearly convey innovative concepts into understandable terms. I have an in-depth understanding of the commercial market and can assess a product’s viability and likelihood of the healthcare industry adopting the technology.Some of my key skills include:☑ FDA Approval Planning ☑ FDA Regulatory Compliance☑ Full Scope Project Management☑ Product and Program Management☑ Clinical Monitoring☑ Clinical Manufacturing☑ Safety Management☑ KPI / Metrics Analysis and Reporting☑ Strategic Planning
Listed skills include Program Management, Project Management, Biotechnology, Global Health, and 15 others.
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United States
Leads the development of regulatory strategy for medical devices, digital health products, combination products, in-vitro diagnostics, and companion diagnostics.
Provides regulatory strategy for medical devices, digital health products, combination products, in-vitro diagnostics, and companion diagnostics. Assists industry partners in interactions with the federal government.
Fort Detrick, Maryland
Lead team of 85 employees and oversee 40 ongoing product development projects and 130+ clinical trials within the USAMRMC. Oversee regulatory and clinical support for all FDA-regulated product development and clinical research within USAMRMC. Took on director role and stood up the ORA as an independent organization when it split from US Army Medical.
Managed cost, schedule and performance for all projects in the Neurotrauma and Psychological Health Portfolio. Provided strategic support for a suite of projects in the Neurotrauma and Psychological Health Project Management Office. Worked and supervised cross-functional team to establish project scope, define team’s roles and responsibilities, optimize.
Managed advanced development efforts and executed project resources for development of medical devices and diagnosis and treatment assays with project budgets up to $100M. Provided solutions and regulatory strategies and oversaw decision gate and development activities for laboratory assay for traumatic brain injury, non-invasive neurodiagnostics.
Department of Biology instructor for BMS 549: Regulation of Medical Devices course that included an overview of the historical development as well as the current status of the laws, regulations and guidelines governing medical devices. Presented key aspects of gaining regulatory approval for all classes of medical devices using various submission processes.
Oversaw advanced development projects for medical devices specializing in non-pharmaceutical respiratory counter-measures as well as pharmaceutical and vaccine delivery devices and diagnostic systems. Worked with and managed interagency agreements with other branches of government to conduct research. Managed procurement efforts for Health and Human.
Rockville, MD
Served as the Branch Chief of Anesthesiology and Respiratory Devices (ARDB) in the Office of Device Evaluation (ODE) from 9/2007 to 9/2008 and as a reviewer in ARDB 1/2004 to 9/2007. Supervised a team of reviewers and reviewed 510(k)s PMAs, IDEs, pre-IDEs, HDE’s, Risk Determinations, Requests for Designation and 513(g)s throughout CDRH. Provided consult.
Other employees you can reach at voisinconsulting.com. View company contacts for 178 employees →
Guru Murthy
Colleague at Voisin Consulting Life Sciences (Vcls)Bengaluru, Karnataka, India, India
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Rajeswari Ummettala
Colleague at Voisin Consulting Life Sciences (Vcls)United States, United States
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Carolye Collins Mahar
Colleague at Voisin Consulting Life Sciences (Vcls)Cambridge, Massachusetts, United States, United States
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Anand Kumar A
Colleague at Voisin Consulting Life Sciences (Vcls)Bengaluru, Karnataka, India, India
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Isabel Mccormack
Colleague at Voisin Consulting Life Sciences (Vcls)Bristol, England, United Kingdom, United Kingdom
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Pavan Kumar R Y
Colleague at Voisin Consulting Life Sciences (Vcls)Bengaluru, Karnataka, India, India
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François Janssens Chevalier
Colleague at Voisin Consulting Life Sciences (Vcls)Greater Paris Metropolitan Region, France
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Soline Malkas
Colleague at Voisin Consulting Life Sciences (Vcls)Greater Nice Metropolitan Area, France
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Gabriella R.
Colleague at Voisin Consulting Life Sciences (Vcls)France, France
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Chetana S
Colleague at Voisin Consulting Life Sciences (Vcls)Bengaluru, Karnataka, India, India
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Quick answers generated from the profile data available on this page.
Michael Husband, Pmp works for Voisin Consulting Life Sciences (VCLS).
Michael Husband, Pmp is listed as Senior Director, Medical Devices and Combination Products at Voisin Consulting Life Sciences (VCLS).
AeroLeads has found 2 work email signals at @voisinconsulting.com for Michael Husband, Pmp at Voisin Consulting Life Sciences (VCLS).
Michael Husband, Pmp is based in Bridgeton, New Jersey, United States while working with Voisin Consulting Life Sciences (VCLS).
Michael Husband, Pmp has worked for Voisin Consulting Life Sciences (Vcls), Eaglelon Consulting, Us Army Medical Research And Materiel Command (Usamrmc), Us Army Medical Materiel Development Activity (Usammda), and United States Army Medical Materiel Agency (Usamma).
Michael Husband, Pmp's colleagues at Voisin Consulting Life Sciences (VCLS) include Guru Murthy, Rajeswari Ummettala, Carolye Collins Mahar, Anand Kumar A, and Isabel Mccormack.
You can use AeroLeads to view verified contact signals for Michael Husband, Pmp at Voisin Consulting Life Sciences (VCLS), including work email, phone, and LinkedIn data when available.
Michael Husband, Pmp holds Master Of Science - Ms, Applied Biomedical Engineering from The Johns Hopkins University.
Michael Husband, Pmp is listed with skills including Program Management, Project Management, Biotechnology, Global Health, Strategic Planning, Policy, Public Health, and Government.
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