Global Director, Regulatory Affairs — Orthopedics

Johnson & Johnson MedTech; Raynham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Director of Regulatory Affairs to lead regulatory strategy across Orthopaedics. The role supports multiple locator sites including Raynham, MA, and coordinates with R&D, Quality, and Global Marketing to enable timely device clearances.

The successful candidate will set strategy, manage complex submissions, and develop a high-performing regulatory team to ensure global compliance and successful product launches in key markets.

Qualifications

• Minimum of a Bachelor's degree in a technical field is required.
• M.S., M.E., PhD or MD is highly preferred.
• Senior leadership experience with regulatory strategy development is required.

Responsibilities

• Set regulatory strategy and lead regulatory submissions for devices.
• Lead and develop regulatory staff and cross-functional partnerships.
• Oversee 510(k), IDE, PMA, and global regulatory filings.
• Define regulatory direction for pipeline development and launches.
• Collaborate with R&D, Quality, and Global Marketing to drive launches.
• Monitor global regulatory changes and advise management on impact.

Skills

Regulatory strategy

Leadership

Cross-functional

Global regulatory

Regulatory submissions

Education

Bachelor's degree (technical)

Advanced degree preferred

Job description

Johnson & Johnson MedTech is seeking a Director of Regulatory Affairs to lead regulatory strategy across Orthopaedics. The role supports multiple locator sites including Raynham, MA, and coordinates with R&D, Quality, and Global Marketing to enable timely device clearances.

The successful candidate will set strategy, manage complex submissions, and develop a high-performing regulatory team to ensure global compliance and successful product launches in key markets.