Director, Global Regulatory Affairs - MedTech Orthopaedics

Brighter Signals; West Chester (Chester County); On-site; USD 164,000 - 283,000; Full time

Benefits offered by this job

Vacation –120 hours/year

Sick time –40 hours/year

13 holidays/year

Parental and personal leave

Job summary

Johnson & Johnson Orthopaedics seeks a Director of Regulatory Affairs to set regulatory strategy and lead global submissions for a broad portfolio of devices. Based in the U.S., you will steer cross-functional teams including R&D, Quality, and Marketing to ensure on-time product clearances and launches.

You will mentor a diverse regulatory staff, influence senior stakeholders, and monitor global regulatory changes.

Qualifications

• Bachelor's degree in technical field required; MS/PhD preferred.
• 10+ years of regulatory experience in regulated industry required.
• Senior leadership experience including line management of multiple levels.

Responsibilities

• Lead and manage global regulatory submissions and approvals for devices.
• Define strategic regulatory direction for pipeline development and global launches.
• Oversee regulatory filings (510(k), IDE, PMA, HDE, etc.) across orthopaedic products.
• Partner with R&D, Quality, Supply Chain and Marketing to execute regulatory plans.
• Develop and mentor Regulatory staff to build future leaders.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Strategic thinking

Regulatory affairs management

Education

Bachelor's degree in technical field

MS/PhD preferred

Job description

Johnson & Johnson Orthopaedics seeks a Director of Regulatory Affairs to set regulatory strategy and lead global submissions for a broad portfolio of devices. Based in the U.S., you will steer cross-functional teams including R&D, Quality, and Marketing to ensure on-time product clearances and launches.

You will mentor a diverse regulatory staff, influence senior stakeholders, and monitor global regulatory changes.