Sr. Director, Regulatory Law, Orthopedics

Sr. Director, Regulatory Law

Locations: New Brunswick, New Jersey; Raynham, Massachusetts; West Chester, Pennsylvania.

Job Description

DePuy Synthes is recruiting for a Sr. Director, Regulatory Law. You will support global regulatory activities in orthopaedics medical device and technology portfolio, provide expert legal counsel, partner with Regulatory Affairs, Quality, R&D, and Commercial teams, and shape regulatory strategy to enable innovation, compliance, and sustainable growth.

Key Responsibilities

• Serve as the senior legal advisor on U.S. and global regulatory law matters for DePuy Synthes portfolio.
• Provide strategic legal counsel on regulatory submissions, product clearances, approvals, post‑market surveillance, recalls, and enforcement actions.
• Collaborate with Regulatory Affairs and Quality leadership to interpret FDA, EU MDR/IVDR, and other global 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 related to off‑label promotion or pre‑clearance activities.
• Lead regulatory legal risk assessments and develop mitigation strategies aligned with business objectives.
• Participate in due diligence for deal activities to assess regulatory compliance or risk.
• Support global inspections, audits, and interactions with regulatory authorities, including preparing and responding to findings.
• Lead or participate in communications with enforcement bodies on a variety of issues.
• Monitor regulatory developments globally and advise the business on required actions or policy changes.
• Develop strategies for influencing regulatory policy and collaborate with Government Affairs partners.
• Supervise the paralegal team supporting cross‑functional copy approval.

Education

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

Required Experience and Skills

• 12-14 years of progressive legal experience, including significant regulatory law experience in a private firm, enforcement body, or medical device/technology company.
• Deep knowledge of FDA regulations and global medical device regulatory frameworks such as EU MDR.
• Global regulatory experience, including collaboration with in‑house or external counsel internationally.
• Experience supporting regulatory inspections, enforcement actions, or major product remediation activities.
• Proven ability to balance legal risk with business strategy in a fast‑paced environment.
• Strong communication and influencing skills for senior executive decision‑making.

Preferred Experience and Skills

• In‑house legal experience supporting a global medical device or medtech organization.
• Familiarity with regulatory guidelines on digital health, software as a medical device (SaMD), robotics, biologics, combination products, or artificial intelligence.
• Experience supporting mergers, acquisitions, or corporate separations in a regulated environment.
• Strong leadership skills collaborating with diverse legal teams.

Other Qualifications

• Language: English (required); additional languages preferred.
• Travel: 15-25% domestically and internationally.
• Certifications: None required.

Pay Range

$178,000.00 - $307,050.00

Benefits

• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (48 hours for Colorado, 56 hours for Washington).
• Holiday pay, including floating holidays – 13 days per calendar year.
• Work, personal and family time – up to 40 hours per calendar year.
• Parental leave – 480 hours within one year of birth/adoption/foster care of a child.
• Bereavement leave – 240 hours for an immediate family member, 40 hours for an extended family member per calendar year.
• Caregiver leave – 80 hours in a 52‑week rolling period (10 days).
• Volunteer leave – 32 hours per calendar year.
• Military spouse time‑off – 80 hours per calendar year.