In House Counsel Jobs New York

In House Counsel Jobs New York | JDHuntr 52548 Lead Counsel, Regulatory, Washington, DC
To apply go to JDHuntr.com
*Provide legal guidance in preparation for audits and inspections by the FDA, and in responding to FDA 483s and enforcement actions, developing remediation work plans, and conducting market withdrawal/recall/field action analyses. *Provide legal advice and guidance regarding FDA regulations including regulation relating to Product Clearances; development strategies, including with respect to clinical trial design and regulatory pathways; regulatory strategy and pre-market applications (including for digital health and other combination products); premarket notifications, including 510(k)s and PMAs; manufacturing; post-market (including any product modifications) and product end-of life. Provide counseling in connection with post-market reporting, including MDR reporting, field corrective actions, CAPA, complaint handling and similar matters. $169,700 - $282,800


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Employment Type: Full-Time
Salary: $ 169,700.00 282,800.00 Per Year