Global Regulatory Strategy Lead – High‑Risk Medical Devices

CryoLife, Inc.; Kennesaw (GA); Hybrid; USD 180,000 - 250,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Artivion, Inc. in the Atlanta area seeks an experienced Senior Director Regulatory Affairs, Product Development to set enterprise-level global regulatory strategy for its new-product portfolio and lead regulatory efforts from feasibility through approval, launch and lifecycle management.

You will manage senior regulatory staff, interact with FDA and global authorities, align regulatory plans with clinical evidence, labeling and marketing strategies, and collaborate across R&D, QA, Operations,

Qualifications

• Bachelor's degree in science, engineering, life sciences or related field required.
• Minimum 12 years of regulatory affairs experience with leadership in medical devices OR 10 years with engineering/advanced degree.
• Experience with Class II/III devices and global submissions (FDA/CE).

Responsibilities

• Set global regulatory strategies for emerging technology and product development.
• Lead portfolio-level regulatory planning for high-risk devices and approvals.
• Represent regulatory affairs to executive leadership and cross-functional teams.
• Oversee timely submissions to global regulatory agencies (FDA, EU MDR, etc.).

Skills

Regulatory strategy

Leadership

Regulatory submissions

Cross-functional

Executive communication

Education

Bachelor's degree in science or engineering

Job description

Artivion, Inc. in the Atlanta area seeks an experienced Senior Director Regulatory Affairs, Product Development to set enterprise-level global regulatory strategy for its new-product portfolio and lead regulatory efforts from feasibility through approval, launch and lifecycle management.

You will manage senior regulatory staff, interact with FDA and global authorities, align regulatory plans with clinical evidence, labeling and marketing strategies, and collaborate across R&D, QA, Operations,