Sr. Director, Regulatory Law, Orthopedics

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Job Function:

Legal & Compliance

Job Sub Function:

Law Business Partners

Job Category:

Professional

All Job Posting Locations:

New Brunswick, New Jersey, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

DePuy Synthes is recruiting for a Sr. Director, Regulatory Law, Orthopedics located in Raynham, MA, New Brunswick, New Jersey, West Chester, Pennsylvania.

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed sometime in 2027, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

The Sr. Director, Regulatory Law serves as a strategic legal leader supporting the global regulatory activities of DePuy Synthes across the orthopedic medical device and technology portfolio. This role provides expert legal counsel on complex regulatory matters, partners closely with Regulatory Affairs, Quality, R&D, and Commercial teams, and helps shape regulatory strategy to enable innovation, compliance, and sustainable growth. This is a highly visible role with significant impact on product development, lifecycle management, and global market access.

Key Responsibilities

• Serve as the senior legal advisor on U.S. and global regulatory law matters affecting medical devices and medical technology across the DePuy Synthes portfolio.

• Provide strategic legal counsel on regulatory submissions, product clearances and approvals, post market surveillance, field actions including recalls, and enforcement actions.

• Partner with Regulatory Affairs and Quality leadership to interpret and apply FDA, EU MDR/IVDR, and other global regulatory requirements.

• Serve on Quality Review Boards.

• Advise on regulatory aspects of product development, clinical investigations, labeling, advertising, and promotional activities, including copy review.

• Advise on commercial activities, including relating to risk of off-label promotion or activities prior to product clearance or approval.

• Lead regulatory legal risk assessments and develop mitigation strategies aligned with business objectives.

• Participate in due diligence for deal activities in order to assess regulatory compliance or risk associated with the transaction.

• Support global inspections, audits, and interactions with regulatory authorities, including preparation and response strategies.

• Advise on responses to any regulatory bodies with respect to audit findings, including observations or warning letters.

• Lead or participate in communications with enforcement bodies on a variety of issues.

• Monitor regulatory developments globally and advise the business on any necessary action or change to policy or procedure.

• Develop and deploy overarching strategy for interacting with and influencing regulatory policy and collaborating with Government Affairs colleagues on those strategies.

• Supervise paralegal providing support for cross-functional copy approval.

Qualifications

Education

• Juris Doctor (JD) from an accredited law school (required).

• Admission to practice law in at least one U.S. jurisdiction (required).

Experience and Skills

Required:

• Typically requires 12-14 years of progressive legal experience, including significant experience in regulatory law with a private law firm, enforcement body or within a medical device, medical technology, life sciences, healthcare company or in another highly regulated industry.

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