Associate Director of Device Regulatory Affairs

Job Summary

Leading regulatory strategies for Class III medical device submissions, the full-time Associate Director of Device Regulatory Affairs will manage a team of global regulatory staff and ensure compliance with health authorities while collaborating cross-functionally to facilitate market access for innovative medical devices in a remote setting.

Key responsibilities:

• Lead global regulatory strategy and develop integrated regulatory pathways for Class III medical device programs
• Direct the preparation and execution of major regulatory submissions for Class III devices
• Serve as a senior regulatory representative in interactions with FDA, EU notified bodies, and UK approved bodies

Required qualifications:

• Bachelor's degree with 10+ years of experience in Regulatory Affairs for Class III implantable medical devices
• At least 5 years of experience with combination product implantable medical devices
• Experience with FDA submissions and EU MDR technical documentation
• Familiarity with global commercialization strategies for medical devices
• Strong leadership and team management skills