Job Summary
A leader in using AI to combat life-threatening vascular and neurovascular conditions needs applicants for an opening for a Remote Regulatory Affairs Project Manager.
Core Responsibilities of this position include:
- Assembling, distributing, storing, tracking and retrieving information pertinent to the regulatory process
- Authoring and publishing electronic submissions
- Managing requests from foreign government and/or distributors as needed
Applicants must meet the following qualifications:
- Strong written/verbal communication and interpersonal skills
- Strong attention to detail; ability to multi-task and balance competing priorities
- Knowledge of overall business environment, the SaMD industry, and the marketplace
- Ability to learn and stay abreast of regulations pertinent to medical devices
- Ability to building relationships between Regulatory Affairs and other areas of the organization
- Knowledge of FDA, EU, and other regulatory body regulations
