Senior Director, Regulatory Law, Orthopedics

Johnson & Johnson

Sr. Director, Regulatory Law for DePuy Synthes at J&J, leading global regulatory strategy in orthopedic medical devices.

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

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.

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

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory lawFDA regulationsEU MDRregulatory submissionsproduct clearancespost-market surveillancerisk assessmentscomplianceclinical investigationscopy review

Soft Skills

strategic legal counselcommunication skillsinfluenceleadershipcollaborationproblem-solvingadvising senior leadersbalancing legal riskdeveloping strategiessupervision