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 for medical devices, including FDA regulations and EU MDR. Proven ability to provide strategic legal counsel, manage regulatory risks, and influence policy within a fast-paced environment.

Highest-signal resume keywords

Juris Doctor (JD)FDA RegulationsRegulatory Law ExperienceRegulatory ComplianceStrong Communication Skills

ATS Keywords

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Hard Skills

Regulatory SubmissionsProduct ClearancesPost-Market SurveillanceRisk AssessmentsLabeling and Advertising ReviewClinical InvestigationsEnforcement ActionsQuality System RequirementsGlobal Medical Device Regulatory FrameworksRegulatory Policy Strategy

Soft Skills

Influencing Executive DecisionsLearning AgilityBalancing Legal Risk with Business Strategy

Certifications & Qualifications

Admission to Practice Law

Industry Keywords

Medical DevicesMedtechGlobal InspectionsDigital HealthSaMDRoboticsBiologicsCombination ProductsArtificial IntelligenceCybersecurity

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 affecting medical devices and medical technology
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 FDA, EU MDR/IVDR, and other global requirements
Serve on Quality Review Boards
Advise on product development, clinical investigations, labeling, advertising, promotional activities, and copy review
Advise on commercial activities and risks of off-label promotion or pre-clearance activity
Lead regulatory legal risk assessments and develop mitigation strategies
Participate in transaction due diligence to assess regulatory compliance and risk
Support global inspections, audits, and interactions with regulatory authorities
Advise on responses to 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 influencing regulatory policy and collaborate with Government Affairs
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, including significant regulatory law experience
In-depth knowledge of FDA regulations, including 510(k), De Novo, PMA, quality system requirements, post-market obligations, and global medical device regulatory frameworks such as EU MDR
Strong pharmaceutical regulatory experience with demonstrated learning agility to build medical device regulatory expertise may also be considered
Experience collaborating with in-house or external counsel across jurisdictions
Experience supporting regulatory inspections, enforcement actions, responses to inspectional observations or warning letters, recalls, and other field actions
Experience advising on labeling, advertising, promotion, copy review, and off-label or 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 required; additional languages preferred
Travel up to approximately 15–25%, domestic and international
Prior in-house legal experience supporting a global medical device or medtech organization preferred
Experience with quality review boards, regulatory policy strategy, regulators, trade associations, Government Affairs, digital health, SaMD, robotics, biologics, combination products, artificial intelligence, cybersecurity, mergers, acquisitions, or corporate separations preferred

Benefits

Comp & perks

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 for employees residing in Colorado; 56 hours 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 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