Regulatory Strategy Director, Medical Devices (Product Development)

Artivion, Inc.; Kennesaw (GA); On-site; USD 180,000 - 240,000; Full time

Job summary

Artivion, Inc. is seeking a Senior Director of Regulatory Affairs, Product Development to set enterprise-level global regulatory strategy for our new product portfolio.

You will lead senior regulatory management, interact with FDA, notified bodies, and global authorities, and ensure compliant execution across regions from feasibility through deployment and lifecycle management. The role requires extensive experience in regulatory strategy for high-risk medical devices, with a focus on

Qualifications

• Bachelor's degree in science, engineering, or related field; advanced degree preferred.
• Extensive experience in regulatory affairs for medical devices; leadership experience required.
• Global regulatory expertise across US/EU/Canada/International markets.

Responsibilities

• Set enterprise-level global regulatory strategy for new product development.
• Lead senior regulatory management and interact with FDA, notified bodies, and global authorities.
• Oversee regulatory submissions and ensure compliance across regions throughout lifecycle.

Skills

Regulatory strategy

Leadership

FDA interactions

Global regulatory

Cross-functional collaboration

Regulatory submissions

Quality systems

Risk management

Project portfolio management

Negotiation

Education

Bachelor's degree in sciences/engineering

Advanced degree preferred

Job description

Artivion, Inc. is seeking a Senior Director of Regulatory Affairs, Product Development to set enterprise-level global regulatory strategy for our new product portfolio.

You will lead senior regulatory management, interact with FDA, notified bodies, and global authorities, and ensure compliant execution across regions from feasibility through deployment and lifecycle management. The role requires extensive experience in regulatory strategy for high-risk medical devices, with a focus on