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Senior Specialist, Combination Product Development
Job in
Montpelier, Washington County, Vermont, 05604, USA
Listed on 2026-07-20
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-20
Job specializations:
-
Engineering
Quality Engineering, Medical Device Industry, Biomedical Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. is seeking an experienced Individual Contributor to lead device development programs for combination products and drug delivery devices.
The role requires expertise in device quality systems (CFR 820, ISO 13485), human factors engineering, risk management (ISO 14971), and technical writing, with 5–8 years in pharma, biotech, or medical devices. The incumbent will manage design history files, support regulatory dossiers, and coordinate human factors studies.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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