Sr. Director, Regulatory Law, Orthopedics

About the role

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.

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.

Requirements

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. Deep knowledge of FDA regulations and global medical device regulatory frameworks (e.g., EU MDR). Global regulatory experience, including collaborating with in-house or outside counsel internationally. Experience supporting regulatory inspections, enforcement actions or major product remediation activities. Demonstrated experience advising senior leaders on complex regulatory and compliance matters. Proven ability to balance legal risk with business strategy in a fast-paced environment. Strong communication skills and ability to influence senior executive decision making.

Skills

• Deep knowledge of FDA regulations and global medical device regulatory frameworks (e.g., EU MDR).
• Global regulatory experience, including collaborating with in-house or outside counsel internationally.
• Experience supporting regulatory inspections, enforcement actions or major product remediation activities.
• Demonstrated experience advising senior leaders on complex regulatory and compliance matters.
• Proven ability to balance legal risk with business strategy in a fast-paced environment.
• Strong communication skills and ability to influence senior executive decision making.

Qualifications

Juris Doctor (JD) from an accredited law school (required). Admission to practice law in at least one U.S. jurisdiction (required).

Benefits

Additional Description For Pay Transparency
This position is eligible to participate in the Company’s long-term incentive program.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits