QA/Regulatory Leader – Medical Devices
ctl amedicaBrooklyn (NY)
About the role
CTL Amedica Corporation seeks an experienced Quality/Regulatory Manager to lead the QA/Regulatory staff and guide compliance across the organization. You will interpret requirements per FDA QMSR, ISO 13485:2016, and ISO 14971, and act as the primary liaison with regulatory bodies.
You will coordinate external audits, manage CAPA and non-conforming materials, and oversee product labeling, release, and post-market surveillance activities.
Before you apply
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Your profile is current
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Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
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Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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