Nathan Wolf Email & Phone Number

• 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.
• 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:

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.