Global Director of Regulatory Affairs - Orthopaedics Devices

Brighter Signals; Florida; On-site; USD 164,000 - 283,000; Full time

Benefits offered by this job

Vacation time

Sick time

Parental Leave

Volunteer Leave

Job summary

Johnson & Johnson’s Orthopaedics regulatory team seeks a Director, Regulatory Affairs to lead global regulatory strategy for devices. Location options include Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA. This role reports to senior regulatory leadership.

You will direct regulatory submissions (510(k), IDE, PMA) and launch excellence, build a strong team, and partner across R&D, Quality, and Global Regulatory Affairs to ensure timely commercialization in line with Credo.

Qualifications

• Bachelor’s degree in a technical discipline is required.
• MS/PhD/MD highly preferred for senior leadership roles.
• Senior leadership experience with regulatory strategy is required.

Responsibilities

• Lead global regulatory submissions and strategy for devices.
• Oversee regulatory staff development and allocation of resources.
• Collaborate with R&D, Quality, Supply Chain, and Marketing on launches.

Skills

Regulatory leadership

Strategic thinking

Cross-functional collab

People management

Regulatory strategy

Communication

Industry analysis

Education

Bachelor’s degree in technical field

MS/MD/PhD preferred

Tools

Regulatory databases

Regulatory affairs software

Job description

Johnson & Johnson’s Orthopaedics regulatory team seeks a Director, Regulatory Affairs to lead global regulatory strategy for devices. Location options include Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA. This role reports to senior regulatory leadership.

You will direct regulatory submissions (510(k), IDE, PMA) and launch excellence, build a strong team, and partner across R&D, Quality, and Global Regulatory Affairs to ensure timely commercialization in line with Credo.