Job Summary

A medical device manufacturing company has an open position for a Remote Med Device Software Regulatory Affairs Manager.

Candidates will be responsible for the following:

• Providing regulatory input to product lifecycle planning, particularly for standalone software medical devices
• Determining classification, submission and approval requirements
• Monitoring and submitting applicable reports and ensuring appropriate responses are submitted to regulatory authorities

Position Requirements Include:

• 5+ years experience in a regulated industry (e.g., medical devices, combination products)
• Knowledge of submission/registration types and requirements
• Knowledge of EU Medical Device Directive and EU Medical Device Regulation
• Domestic and international regulatory guidelines, policies and regulations, particularly as applied to standalone software
• Knowledge of GxPs (GCPs, GLPs, GMPs), ISO 13485