Senior 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.