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Nathan Wolf is listed as CER Author | Regulatory Consultant at Wolf Regulatory Consulting LLC, based in Phoenix, Arizona, United States. AeroLeads shows a work email signal at bucknell.edu and a matched LinkedIn profile for Nathan Wolf.
Nathan Wolf previously worked as Regulatory Consultant at Wolf Regulatory Consulting Llc and Regulatory Specialist at Acumed. Nathan Wolf holds B.S., Biomedical Engineering from Bucknell University.
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Experienced in medical device postmarket clinical assessments and monitoring. Focused on providing clients with compelling, high-quality CERs. Exploring the future of performance analytics in the medical device industry.
Listed skills include Medical Devices, Biomedical Engineering, Fda, Product Development, and 16 others.
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Experienced medical device regulatory consultant, with a strong understanding of complex medical device product development. Focused on providing compelling medical device clinical performance assessments by leveraging qualifications in:• Regulatory Affairs• Engineering• Patient Safety Analysis• Technical, Scientific and Medical Writing• Data Analytics
Hillsboro, Or
Acumed is a global medical device company that provides orthopedic implant and instrumentation solutions. As a Regulatory Specialist, accomplishments included:Planning and authoring domestic regulatory deliverables:• FDA CDRH 510(k) submissions• 510(k) purchase/transfer documentation• Class II product distributor documentation• Class I 510(k) exempt product assessments and listings• Significant Change assessmentsCreating and compiling regulatory documentation for numerous international initiatives:• New and revised Technical Files for Notified Body review (CE Marking)• Health Canada amendments and applications• Registration documentation for India (DCGI), Japan (PMDA), Mexico (COFEPRIS), Peru (DIGEMID), Brazil (ANVISA), and Colombia (INVIMA)Planning global regulatory pathways, and integrating registration activities into new product development lifecyclesReviewing and/or approving technical and marketing documentation:• Mechanical testing protocols and reports• Inputs, Outputs, Verification and Validation (IOVV) plans• Risk Management Reports (RMRs)• Clinical evaluation reports (CDRs/CERs)• Health Hazard Evaluation (HHE) / product recall documentation• Instructions for use and surgical techniques• Promotional material
Designed and developed an innovative emergency room intubation device, working within a small team of Geisinger Health System physicians, as well as Bucknell Biomedical Engineering students and faculty.
Lewisburg, Pa
Utilized COMSOL and MATLAB to model fluid-structure interaction for peristaltic flow around obstructions for the Bucknell Biomedical Engineering Department
Beaverton, Or
Participated in development of "Assisted Movement with Enhanced Sensation" active stroke therapy for AMES Technology Inc/the Cordo Lab.Developed systems for tracking and analyzing multi-site late phase clinical trial data.
Portland, Or
Managed an ethanol-nicotine pharmacokinetics study using mice from IACUC approval through study completion.
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Nathan Wolf works for Wolf Regulatory Consulting LLC.
Nathan Wolf is listed as CER Author | Regulatory Consultant at Wolf Regulatory Consulting LLC.
AeroLeads has found 2 work email signals at @bucknell.edu for Nathan Wolf at Wolf Regulatory Consulting LLC.
Nathan Wolf is based in Phoenix, Arizona, United States while working with Wolf Regulatory Consulting LLC.
Nathan Wolf has worked for Wolf Regulatory Consulting Llc, Acumed, Bucknell University, and Ohsu.
You can use AeroLeads to view verified contact signals for Nathan Wolf at Wolf Regulatory Consulting LLC, including work email, phone, and LinkedIn data when available.
Nathan Wolf holds B.S., Biomedical Engineering from Bucknell University.
Nathan Wolf is listed with skills including Medical Devices, Biomedical Engineering, Fda, Product Development, Regulatory Submissions, Technical Documentation, Design Control, and Regulatory Guidelines.
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