Senior Director, Regulatory Law, Orthopedics

Johnson & Johnson

Strategic legal leader managing regulatory compliance for orthopedic medical devices at DePuy Synthes. Advising on legal matters and supporting global regulatory activities.

Posted 5/1/2026full-timeRaynham • Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $178,000 - $307,050 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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 in 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
English (required); additional languages preferred

Benefits

Comp & perks

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Hard Skills & Tools

regulatory lawFDA regulationsEU MDRregulatory submissionsproduct clearancespost-market surveillancerisk assessmentscompliance matterslegal risk mitigationclinical investigations

Soft Skills

strategic legal counselcommunication skillsinfluence decision makingcollaborationleadershipadvising senior leadersbalancing legal riskproblem-solvingcross-functional teamworkmonitoring regulatory developments

Certifications

Juris Doctor (JD)admission to practice law