Senior Regulatory Affairs Specialist

Job Summary

Acting as the Regulatory Affairs Lead, the full-time contract Senior Regulatory Affairs Specialist will drive global regulatory compliance and market expansion for medical device technologies, ensuring alignment with international standards while working remotely with a preference for candidates near Memphis, TN.

Key responsibilities

• Lead the preparation, review, and execution of complex regulatory submissions, including US FDA 510(k) notifications and EU MDR technical documentation
• Serve as the primary Regulatory Affairs representative on cross-functional project teams, establishing regulatory strategies and compliance pathways
• Develop and refine Standard Operating Procedures (SOPs) to align with global regulatory frameworks and support audit readiness

Required qualifications

• Bachelor's degree in a scientific, engineering, or technical discipline or equivalent professional experience
• 3-5 years of regulatory affairs experience within the medical device sector with a track record of commercial clearances
• Experience utilizing Product Lifecycle Management (PLM) systems and managing regulatory workflows
• Specialized expertise in authoring EU MDR technical documentation and understanding US FDA 510(k) submission pathways