Senior Director, Regulatory Law, Orthopedics

Johnson & Johnson

. Serve as senior legal advisor on U.S.

Posted 10/23/2026full-timeUnited StatesSenior💰 $178,000 - $307,050 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in U.S. and global regulatory law, particularly within the medical device and technology sectors, with a strong focus on FDA regulations and compliance. Proven ability to provide strategic legal counsel, influence regulatory policy, and manage complex legal risks while aligning with business objectives.

Highest-signal resume keywords

Regulatory Law ExperienceFDA Regulations KnowledgeStrategic Legal CounselCommunication SkillsLeadership Skills

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsProduct ClearancesPost-Market SurveillanceRisk AssessmentsLabeling and Advertising ComplianceClinical InvestigationsEnforcement ActionsQuality System RequirementsAdverse Event ReportingGlobal Medical Device Regulatory Frameworks

Soft Skills

Influencing Executive DecisionsCollaboration Across JurisdictionsBalancing Legal Risk with Business Strategy

Certifications & Qualifications

Juris Doctor (JD)Admission to Practice Law

Industry Keywords

Medical DeviceHealthcareLife SciencesRegulated IndustryDigital HealthSoftware as a Medical DeviceRoboticsBiologicsCombination ProductsCybersecurity

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Serve as senior legal advisor on U.S. and global regulatory law matters for DePuy Synthes’ orthopedic medical device and technology portfolio
Provide strategic counsel on regulatory submissions, product clearances and approvals, post-market surveillance, recalls, field actions, 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 product development, clinical investigations, labeling, advertising, promotional activities, and copy review
Advise on commercial activities involving off-label promotion and activities before product clearance or approval
Lead regulatory legal risk assessments and develop mitigation strategies aligned with business objectives
Participate in deal due diligence to assess regulatory compliance and transaction risk
Support global inspections, audits, and interactions with regulatory authorities
Prepare strategies and responses for audit findings, observations, and warning letters
Lead or participate in communications with enforcement bodies
Monitor global regulatory developments and advise on policy or procedural changes
Develop strategy for interacting with and influencing regulatory policy
Collaborate with Government Affairs colleagues on regulatory policy strategies
Supervise a paralegal supporting 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 12-14 years of progressive legal experience
Significant regulatory law experience with a private law firm, enforcement body, medical device, medical technology, life sciences, healthcare company, or another highly regulated industry
In-depth knowledge of FDA regulations, including 510(k), De Novo, PMA, quality system requirements, post-market obligations, complaint handling, adverse event reporting, field actions, and global medical device regulatory frameworks such as EU MDR
Strong pharmaceutical regulatory experience may be considered with demonstrated learning agility to build medical device regulatory expertise
Experience collaborating with in-house or external counsel across jurisdictions
Experience supporting regulatory inspections and enforcement actions, including responses to inspectional observations or warning letters, recalls, and other field actions
Experience advising on labeling, advertising, promotion, copy review, off-label promotion, and pre-clearance promotion risks
Proven experience advising senior leaders on complex regulatory and compliance matters
Strong communication skills and ability to influence executive decisions
Proven ability to balance legal risk with business strategy in a fast-paced environment
English language required; additional languages preferred
Travel up to approximately 15–25%, domestic and international
Certifications: None required
Preferred: prior in-house legal experience supporting a global medical device or medtech organization
Preferred: experience participating in quality review boards or similar cross-functional decision forums
Preferred: experience developing regulatory policy strategy and engaging with regulators, trade associations, or Government Affairs teams
Preferred: familiarity with digital health, software as a medical device, robotics, biologics, combination products, or artificial intelligence
Preferred: understanding of cybersecurity across the medical device lifecycle
Preferred: experience supporting mergers, acquisitions, or corporate separations in a regulated environment
Preferred: strong leadership skills with experience collaborating across different legal environments

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing 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/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
Inclusive interview process and disability accommodations