Senior Regulatory Affairs Principal - Remote

Overview

The Senior Regulatory Affairs Principal is responsible for developing and executing regulatory strategies for DeepHealth’s high risk products, ensuring compliance with global regulations, and leading the process to obtain and maintain market approval.

In Short

• Develop and execute regulatory strategies for FDA Class III devices.
• Provide strategic input on product lifecycle planning.
• Manage regulatory submissions, including FDA interactions.
• Ensure compliance for regulatory submissions and filings.
• Monitor global regulations to ensure compliance.
• Create and maintain technical documentation for regulatory approval.
• Work cross-functionally with various teams.
• Interact with US and OUS Regulatory Authorities.
• Knowledge of pre- and post-market clinical studies.
• Excellent written and oral communication skills.

Requirements

• Bachelor’s degree in life science, engineering, or related field.
• 13 - 17 years in a regulated industry.
• Strong knowledge of FDA Quality System Regulations.
• Experience with regulatory filings for medical devices.
• Experience with US FDA Class III devices.
• International submission experience preferred.
• Knowledge of Medical Devices Regulations.
• Excellent communication skills.

Benefits

• Remote work flexibility.
• Opportunity for international travel.
• Competitive salary range.
• Work in a cross-functional team environment.