Director, Regulatory Affairs

Sr. Director, Regulatory Law (DePuy Synthes) Location: Raynham, MA; New Brunswick, NJ; West Chester, PA. 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 transactions. 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, 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 collaborate with Government Affairs colleagues. Supervise a paralegal providing support for cross‑functional copy approval. Education & Qualifications Juris Doctor (JD) from an accredited law school (required). Admission to practice law in at least one U.S. jurisdiction (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 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. Preferred Experience 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. Additional language skills beyond English. Other Requirements Travel: Up to 15–25% domestic and international. Certifications: None required. Compensation The anticipated base pay range for this position is $178,000.00 – $307,050.00. The position is eligible to participate in the company’s long‑term incentive program. Benefits Vacation – 120 hours per calendar year. Sick time – 40 hours per calendar year (48 hours for employees in Colorado, 56 hours for employees in 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 the birth, adoption or 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. #J-18808-Ljbffr