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Regulatory Affairs Specialist
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Full-time
- The Regulatory Affairs Specialist (RAS) works to gain successful 510k approval by leveraging their skills and expertise to anticipate regulatory requirements and integrate compliance into project plans.
- The RAS streamlines preparation and submissions, by ensuring documentation is accurate, complete, organized and accessible.
- The RAS will work effectively with other departments to compile information and ensure that compliance requirements are met throughout the product lifecycle.
- Represents regulatory affairs and serves as a liaison between regulatory bodies when working with cross-functional teams by providing regulatory feedback and guidance throughout the product development cycle.
- Develop and maintain positive and professional relationships with device reviewers through oral and written communications.
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