Sr. Director, Regulatory Law, Orthopedics

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Job Function:

Legal & Compliance

Job Sub Function:

Law Business Partners

Job Category:

Professional

All Job Posting Locations:

New Brunswick, New Jersey, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

DePuy Synthes is recruiting for a Sr. Director, Regulatory Law, Orthopedics located in Raynham, MA, New Brunswick, New Jersey, West Chester, Pennsylvania.

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed sometime in 2027, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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.

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 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.

Qualifications

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:

•            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.

•            In-depth knowledge of FDA regulations, including premarket pathways (e.g., 510(k), De Novo, PMA), quality system requirements, and post-market obligations covering complaint handling, adverse event reporting, field actions and global medical device regulatory frameworks (e.g., EU MDR).  Candidates with strong pharmaceutical regulatory experience and demonstrated learning agility to build medical device regulatory expertise will also be considered.

•             Experience collaborating with in-house or external counsel across jurisdictions.

•            Experience supporting regulatory inspections, and enforcement actions or, including responses to inspectional observations or warning letters, and major product remediation activities such as recalls and other field actions.

•            Experience advising on labeling, advertising, and promotion, including copy review and the risks of off-label or pre-clearance promotion.

•            Proven experience advising senior leaders on complex regulatory and compliance matters, with strong communication skills and the ability to influence executive decisions.

•            Proven ability to balance legal risk with business strategy in a fast paced environment.

Preferred:

•            Prior in-house legal experience supporting a global medical device, medtech organization.

•            Experience participating in quality review boards or similar cross-functional decision forums on product quality, field actions, and regulatory reporting.

•            Experience developing regulatory policy strategy and engaging with regulators, trade associations, or Government Affairs teams on policy matters.

•            Familiarity with regulatory guidelines on digital health, software as a medical device (SaMD), robotics, biologics, combination products or artificial intelligence.

•            Understanding of cybersecurity considerations across the medical device lifecycle, including product development, post-market updates, and lifecycle management.

•            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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

#DePuySynthesCareers

Required Skills:

Preferred 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

The anticipated base pay range for this position is :

$178,000.00 - $307,050.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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/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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year