Director, Regulatory Affairs

Director-level regulatory affairs leader needed for Johnson & Johnson's Orthopaedics division across multiple US locations. Position develops global regulatory strategies, manages submission processes for medical devices, and leads a regulatory team to ensure timely product approvals and commercialization.

Responsibilities

• Lead regulatory submissions and approvals with government agencies for orthopaedic products
• Develop and execute worldwide regulatory strategies for pipeline advancement and product launches
• Oversee regulatory operations, set strategic direction, and communicate business objectives
• Manage and mentor regulatory staff while assessing departmental competencies and needs
• Collaborate with R&D, Quality, Supply Chain, and Marketing on product development strategy

Requirements

• Extensive experience in regulatory affairs for medical devices or biologics
• Demonstrated ability to lead and develop high-performing regulatory teams
• Deep knowledge of FDA submission processes including 510(k), PMA, IDE, and HDE
• Strategic experience with global regulatory requirements and multi-market approvals
• Strong cross-functional collaboration and stakeholder influence skills
• Understanding of medical device lifecycle management and quality systems