Global Regulatory Law Director – Orthopedics MedTech

Johnson & Johnson Co.; Raynham (MA); On-site; USD 178,000 - 307,000; Full time

Benefits offered by this job

Long-term incentive program

Holiday pay

Vacation – 120 hours

Job summary

Johnson & Johnson, DePuy Synthes unit, seeks a Sr. Director, Regulatory Law, Orthopedics, to guide global regulatory strategy for the orthopedics portfolio from Raynham, MA.

You will partner with Regulatory Affairs, Quality, R&D, and Commercial teams to enable compliant product development and market access, with impact on lifecycle management and strategic deals. The role requires JD, US bar admission, and 12–14 years of regulatory experience in medical devices or life sciences, with strong

Qualifications

• JD from an accredited law school
• Admission to practice law in at least one U.S. jurisdiction
• 12–14 years of progressive legal experience in regulatory law

Responsibilities

• Serve as senior legal advisor on U.S. and global regulatory law matters affecting medical devices and regulatory portfolio.
• Provide strategic counsel on regulatory submissions, product clearances, post-market surveillance, and recalls.
• Partner with Regulatory Affairs and Quality to interpret FDA, EU MDR/IVDR, and global requirements.
• Advise on labeling, advertising, and promotion, including copy review and off-label risk.
• Lead regulatory risk assessments and mitigation strategies aligned with business objectives.

Skills

Regulatory law

FDA regulations

Leadership

Cross-functional

Education

Juris Doctor (JD)

Bar admission

Job description

Johnson & Johnson, DePuy Synthes unit, seeks a Sr. Director, Regulatory Law, Orthopedics, to guide global regulatory strategy for the orthopedics portfolio from Raynham, MA.

You will partner with Regulatory Affairs, Quality, R&D, and Commercial teams to enable compliant product development and market access, with impact on lifecycle management and strategic deals. The role requires JD, US bar admission, and 12–14 years of regulatory experience in medical devices or life sciences, with strong