Job Title: Regulatory Affairs Specialist – Medical device Experience
Job Location: Raleigh, NC
Job Type: 8+ Months contract
Job Description:
The Regulatory Affairs Specialist will be responsible for supporting regulatory activities for existing US FDA class III medical devices. This role provides support to currently marketed products, involves evaluating proposed product and process changes, assessing documentation and providing guidance to ensure regulatory compliance. The Regulatory Affairs Specialist will work collaboratively with internal stakeholders.
From preparing and authoring regulatory submissions to providing critical input on cross-functional project teams and developing regulatory strategy, this role is an excellent opportunity for the right regulatory professional. The ideal candidate will be curious, analytical and a self-starter, unafraid to ask questions or over-communicate.
Job Responsibilities:
Skills & Experience Required:
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