Senior Regulatory Director, Orthopedics MedTech

Brighter Signals; New Brunswick (NJ); 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, including Floating_Holyd

Parental Leave – 480 hours within one年

Volunteer Leave – 32 hours per calenda

Job summary

DePuy Synthes is seeking a Sr. Director, Regulatory Law to lead global regulatory activities across the orthopedic medical device portfolio.

You will provide strategic legal counsel, shape regulatory strategy, and partner with Regulatory Affairs, Quality, R&D and Commercial teams to enable compliant growth. This high-visibility role requires deep FDA/EU MDR knowledge, strong leadership, and the ability to influence senior leaders in a fast-paced environment.

Qualifications

• JD from an accredited law school and U.S. bar admission.
• 12–14 years in progressive regulatory law with a regulated industry.
• Experience with FDA, EU MDR/IVDR and post-market requirements.

Responsibilities

• Serve as senior legal advisor on U.S. and global regulatory law for medical devices.
• Provide strategic counsel on submissions, clearances, and post-market actions.
• Lead regulatory risk assessments and cross-functional collaboration.
• Support regulatory inspections and responses to authorities.
• Advise on labeling, advertising, and cross-border regulatory matters.
• Participate in due diligence for M&A and regulatory risk assessments.
• Lead or participate in communications with enforcement bodies.

Skills

Regulatory law

FDA regulations

Leadership

Communication with senior leaders

Education

Juris Doctor (JD)

Bar admission in the U.S.

Job description

DePuy Synthes is seeking a Sr. Director, Regulatory Law to lead global regulatory activities across the orthopedic medical device portfolio.

You will provide strategic legal counsel, shape regulatory strategy, and partner with Regulatory Affairs, Quality, R&D and Commercial teams to enable compliant growth. This high-visibility role requires deep FDA/EU MDR knowledge, strong leadership, and the ability to influence senior leaders in a fast-paced environment.