Senior Director, Global Regulatory Affairs – MedTech

Johnson Johnson; Raynham (MA); On-site; USD 164,000 - 283,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick leave 40 hours/year

Holiday pay

Parental leave 480 hours/year

Volunteer Leave 32 hours/year

Job summary

Johnson & Johnson is seeking a Director, Regulatory Affairs to lead regulatory strategy for orthopaedics in multiple U.S. locations, including Raynham, MA. The role drives global submissions and launch excellence across regulatory programs with cross-functional partners.

The position requires senior leadership experience and a strong track record in regulatory strategy, lifecycle management, and collaboration with R&D, Quality, and GSM teams.

Qualifications

• Bachelor's degree in a technical field required.
• MS/ME/PhD or MD highly preferred.
• Senior leadership experience required; track record of global regulatory strategies.

Responsibilities

• Leads and manages submissions to government regulatory agencies with global strategies.
• Oversees regulatory submissions and files (510(k)s, IDE/IDE Supplements, PMA/PMA Supplements, etc.).
• Defines strategic regulatory direction for pipeline development and global launches; partners with cross-functional leaders.

Skills

Leadership

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Strategic Thinking

Education

Bachelor's degree in technical field

MS/ME/PhD/MD preferred

Job description

Johnson & Johnson is seeking a Director, Regulatory Affairs to lead regulatory strategy for orthopaedics in multiple U.S. locations, including Raynham, MA. The role drives global submissions and launch excellence across regulatory programs with cross-functional partners.

The position requires senior leadership experience and a strong track record in regulatory strategy, lifecycle management, and collaboration with R&D, Quality, and GSM teams.