Regulatory Affairs SME (Submissions)

NJ

Job ID: 117189 Industry: Quality

 

Regulatory Affairs SME (Submissions)

Environment:

Our client is a clinical-stage biotherapeutics company which develops a number of different combination medical devices focused on treating cardiac diseases. This client is currently in need of a Regulatory Affairs Submissions SME to come in and support the creation of a number of different Regulatory Submissions.    

Principle Duties and Responsibilities:

The consultant will be working on the regulatory team. Because our client a clinical and research-stage organization, the consultant will be dealing primarily with writing and organizing Investigational New Drug Applications (IND), and Investigational Device Exemptions (IDE). It is a necessity that the consultant has experience writing these specific submissions for FDA approval. The candidate should have a strong regulatory background from a pre-clinical and clinical perspective, ideally for both medical devices and pharmaceuticals.   They need to be comfortable reviewing technical content, and reading clinical data/reports. The individual will work cross-functionally with various departments to provide regulatory strategy from a domestic and international standpoint such as regulatory risk assessments. Additional responsibilities could involve product label reviews, promotional/advertising reviews, and regulatory submissions.

 

Required:

·         Medical Device & Pharmaceuticals

·         Clinical-Stage Regulatory Affairs

·         IND Applications

·         IDE Submissions

·         Reading/Reviewing/Feedback on technical content, reports

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