Overview
On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 9 Month(s)
Skills
Documentation
Testing
Job Details
Location - Wayne NJ
This role requires more than regulatory knowledge we need someone who brings deep system-level product validation expertise, can identify validation/test gaps, and guide the team toward submission readiness.
Ideal background:
Strong hands-on validation of Class II medical devices
Experience with 510(k) strategies & execution
Comfortable working under FDA scrutiny/consent decree environments
Skilled in defining appropriate testing levels & documentation
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