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account management medical devices npi iso 13485 21 cfr part 11π Description
- Serve as primary point of contact for customer accounts.
- Coordinate cross-functional collaboration across departments.
- Guide customers through hardware/software validation (IQ/OQ/PQ) and CSV.
- Identify and quantify business impact, demonstrating ROI.
- Proactively manage renewals, mitigate churn, and drive expansion.
- Build relationships via business reviews, success plans, and adoption check-ins.
π― Requirements
- Engineering B.S. degree or equivalent technical experience
- 10+ years in consulting/program management or medical devices development/manufacturing
- Understanding of medical device development, NPI, and manufacturing
- Familiarity with ISO 13485, 21 CFR Part 11, and device lifecycles
- Excellent verbal and written communication across levels
- Extremely organized; thrives in a fast-paced startup
π Benefits
- Competitive cash and equity compensation
- Health and wellness stipend
- 401k
- Parental leave
- Flexible PTO
- Commuter benefits
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