Sr. Director, Regulatory Law, Orthopedics

Job Description DePuy Synthes is recruiting for a Sr. Director, Regulatory Law, located in Raynham, MA; New Brunswick, NJ; and West Chester, PA. Following the planned separation of our Orthopaedics business, the incumbent will become an employee of DePuy Synthes and will be governed by its employment processes, programs, policies, and benefit plans. 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, partnering closely with Regulatory Affairs, Quality, R&D, and Commercial teams to shape regulatory strategy and enable innovation, compliance, and sustainable growth. 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 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 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 regulatory bodies with respect to audit findings, 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 necessary actions or policy changes. Develop and deploy overarching strategy for interacting with and influencing regulatory policy and collaborating with Government Affairs colleagues. Supervise paralegal providing support for 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). Experience and Skills – Required 12–14 years of progressive legal experience, including significant regulatory law experience in a private law firm, enforcement body, or within a medical device, medical technology, life sciences, or healthcare company. Deep knowledge of FDA regulations and global medical device regulatory frameworks (e.g., EU MDR). Global regulatory experience, including collaboration 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. Experience and Skills – Preferred Prior 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 with experience collaborating with colleagues in different legal environments. Other Language: English (required); additional languages preferred. Travel: Up to 15–25%, domestic and international. Certifications: None required. For more information on our employee wellness and benefits, visit Compensation Anticipated base pay range: $178,000.00 – $307,050.00. Position is eligible for the Company’s long‑term incentive program. Benefits Summary Vacation: 120 hours per calendar year. Sick time: 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents). 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. Volunteer Leave: 32 hours per calendar year. Military Spouse Time‑Off: 80 hours per calendar year. Relevant Skills Business Agility, Commercial Laws, Compliance Management, Corporate Governance, Critical Thinking, Dispute Resolution, Document Management, Industry Analysis, Lawyering, Legal Services, Negotiation, Policy Change, Program Management, Representing, Resource Management, Strategic Thinking. #J-18808-Ljbffr Dormont Manufacturing Co