Global Director, Regulatory Affairs — Orthopedics

Johnson & Johnson Co.; Florida; On-site; USD 164,000 - 283,000; Full time

Job summary

Johnson & Johnson, a leader in Orthopaedics, seeks a Director, Regulatory Affairs to set regulatory strategy for Orthopaedics products, located in multiple sites: Palm Beach Gardens, FL; West Chester, PA; Warsaw, IN; Raynham, MA.

You will lead regulatory staff, ensure timely clearances, and collaborate with R&D, Quality, and Marketing to drive launches.

This role offers competitive compensation and comprehensive benefits; Johnson & Johnson is an equal opportunity employer.

Qualifications

• Bachelor's degree in a technical field required; advanced degrees preferred.
• 10+ years of regulatory experience in medical devices or biotech.
• Senior leadership experience with global regulatory strategy delivery.

Responsibilities

• Set regulatory strategy and lead global regulatory submissions.
• Provide guidance to staff and develop regulatory processes.
• Oversee submissions like 510(k), IDE, PMA across devices.
• Partner with R&D, Quality, Supply Chain and Marketing.
• Monitor global regulatory changes and advise management.
• Develop training for cross-functional partners on regulatory requirements.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in a technical field

MS/MD/PhD preferred

Job description

Johnson & Johnson, a leader in Orthopaedics, seeks a Director, Regulatory Affairs to set regulatory strategy for Orthopaedics products, located in multiple sites: Palm Beach Gardens, FL; West Chester, PA; Warsaw, IN; Raynham, MA.

You will lead regulatory staff, ensure timely clearances, and collaborate with R&D, Quality, and Marketing to drive launches.

This role offers competitive compensation and comprehensive benefits; Johnson & Johnson is an equal opportunity employer.