Director, Global Regulatory Affairs — Orthopaedics

Johnson & Johnson MedTech; West Chester (Chester County); On-site; USD 180,000 - 260,000; Full time

Job summary

Johnson & Johnson seeks a Director of Regulatory Affairs to lead the Orthopaedics regulatory team across multiple U.S. sites in Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA. The role shapes regulatory strategy, guides global submissions, and ensures compliant commercialization of innovative orthopaedic devices.

You will mentor regulatory staff, partner with R&D, Quality, and Marketing, and influence policy across markets to maximize patient access to new technologies.

Qualifications

• Bachelor's degree in a technical field (MS/ME/PhD or MD preferred).
• 10+ years of regulated industry experience, preferably with medical devices and digital surgical robotics.
• Senior leadership experience with multiple levels of reporting.

Responsibilities

• Set regulatory strategy and lead global regulatory submissions for devices and related products.
• Provide direction and leadership to Regulatory staff and cross-functional teams.
• Develop and implement global regulatory strategies and processes for timely product commercialization.
• Partner with R&D, Quality, Supply Chain, and Marketing for pipeline development and launches.
• Ensure alignment with global regulatory requirements and communicate regulatory changes to management.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory staff development

Strategic thinking

Regulatory affairs for devices

Education

Bachelor's degree in technical field

MS/ME/PhD or MD preferred

Job description

Johnson & Johnson seeks a Director of Regulatory Affairs to lead the Orthopaedics regulatory team across multiple U.S. sites in Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA. The role shapes regulatory strategy, guides global submissions, and ensures compliant commercialization of innovative orthopaedic devices.

You will mentor regulatory staff, partner with R&D, Quality, and Marketing, and influence policy across markets to maximize patient access to new technologies.