Senior Director, Global Regulatory Law – Orthopedics

Brighter Signals; Raynham (MA); On-site; USD 178,000 - 307,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days per calendar yr

Parental Leave – 480 hours within one

Job summary

Johnson & Johnson is recruiting a Sr. Director, Regulatory Law, Orthopedics, to lead global regulatory strategy for DePuy Synthes.

Based in Raynham, MA, this role shapes regulatory policy, oversees complex submissions, and partners with Regulatory Affairs, Quality, R&D, and Commercial teams to enable innovation and compliant growth. The successful candidate provides strategic counsel on regulatory submissions, inspections, recalls, and post-market activities, while guiding cross-functional teams

Qualifications

• Typically requires extensive experience in regulatory law for medical devices or life sciences industries.
• Strong knowledge of FDA submissions (510(k), De Novo, PMA) and post-market requirements.
• Experience advising senior leaders and coordinating with cross-functional teams.

Responsibilities

• Serve as the senior legal advisor on U.S. and global regulatory law matters affecting medical devices and medical technology.
• Provide strategic legal counsel on regulatory submissions, approvals, post-market actions, and enforcement matters.
• Collaborate with Regulatory Affairs, Quality, R&D and Commercial teams to shape regulatory strategy and policy.
• Advise on labeling, advertising, and copy review to mitigate off-label risks and ensure regulatory compliance.
• Lead regulatory risk assessments and mitigation aligned with business objectives.

Skills

Regulatory law

FDA regulations

Leadership

Cross-functional collaboration

Communication

Regulatory inspections

Education

Juris Doctor (JD)

Admission to practice law in at least one U.S. jurisdiction

Job description

Johnson & Johnson is recruiting a Sr. Director, Regulatory Law, Orthopedics, to lead global regulatory strategy for DePuy Synthes.

Based in Raynham, MA, this role shapes regulatory policy, oversees complex submissions, and partners with Regulatory Affairs, Quality, R&D, and Commercial teams to enable innovation and compliant growth. The successful candidate provides strategic counsel on regulatory submissions, inspections, recalls, and post-market activities, while guiding cross-functional teams