Senior Regulatory Leader, Medical Device Product Dev

RiseMe; Kennesaw (GA); On-site; USD 180,000 - 280,000; Full time

Job summary

Artivion, Inc. is seeking a Senior Director of Regulatory Affairs, Product Development to own enterprise-level global regulatory strategy for new product development and to lead complex, high-risk medical device programs from feasibility through lifecycle expansion.

You will manage senior regulatory staff, interact with FDA and other authorities, and influence regulatory decisions across regions while aligning with clinical evidence strategies and compliance standards.

Qualifications

• Bachelor's degree required in science, engineering, life sciences or related discipline; advanced degree in a relevant focus area preferred.
• Minimum 12 years of experience in regulatory affairs or the medical device industry with bachelor's degree, including significant leadership experience.
• Experience defining and executing global regulatory strategies for Class II/III and high-risk medical devices.
• Proven success leading submissions and approvals (IDE, PMA, HDE, CE marking) and international registrations.

Responsibilities

• Establish, approve and oversee global regulatory strategies for emerging technology and market access.
• Lead portfolio-level regulatory planning for complex high-risk devices.
• Serve as senior regulatory representative to executive leadership and cross-functional teams.
• Oversee and ensure timely submissions to global regulatory agencies (FDA, EU MDR, etc.).
• Lead negotiations with regulatory authorities and prepare for agency interactions.
• Advise on clinical evidence strategies to support global approvals.
• Interpret evolving global regulations and drive compliant innovation and market access.
• Partner with R&D, Quality, Operations, Marketing and Legal to integrate regulatory requirements into design and launch readiness.
• Direct regulatory assessments for new technologies and product changes.
• Mentor and develop Regulatory Affairs team; manage budgets and metrics.

Skills

Regulatory leadership

Global regulatory strategy

FDA interactions

Project portfolio management

Executive communication

Regulatory compliance

Regulatory risk assessment

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Artivion, Inc. is seeking a Senior Director of Regulatory Affairs, Product Development to own enterprise-level global regulatory strategy for new product development and to lead complex, high-risk medical device programs from feasibility through lifecycle expansion.

You will manage senior regulatory staff, interact with FDA and other authorities, and influence regulatory decisions across regions while aligning with clinical evidence strategies and compliance standards.