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Regulatory Affairs Specialist - Medical Devices

VIVA • Skaneateles, NY, US • published 2026-11-05 12:59:21.387522

Description

Hybrid with the possibility of fully Remote Serve as the Regulatory Affairs core team representative for EU MDR compliance and lifecycle activities supporting the client Connected Monitoring and Respiratory Health medical products, including associated software. Execute assigned regulatory activities, maintain documentation, assess product changes, and support cross\-functional project teams. Essential Duties and Responsibilities: This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned. Serve as the RA core team representative for assigned Connected Monitoring and Respiratory Health products, including software. Execute EU MDR regulatory activities for product changes, technical documentation, submissions, and lifecycle maintenance. Assess product changes for EU MDR impact, identify compliance gaps and risks, and escalate issues as appropriate. Prepare, review, and maintain EU MDR technical documentation and regulatory deliverables. Develop clear regulatory assessments and justifications with support from senior RA staff as needed. Support interactions and responses to EU Notified Bodies and regulatory ...

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