Device Safety Officer

Johnson & Johnson

Device Safety Officer ensuring medical safety excellence in medical devices at Johnson & Johnson. Responsible for assessment, documentation, and collaboration in device risk management.

Posted 7/23/2026full-timeRaritan • New Jersey, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $199,000 - $343,850 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical device risk management, including the ability to conduct thorough product risk assessments and effectively communicate complex safety topics. Leverages AI-enabled tools to enhance decision-making and streamline processes while ensuring compliance across diverse stakeholders.

Highest-signal resume keywords

Medical Device Risk ManagementProduct Risk AssessmentCross-Disciplinary Team LeadershipStrong Written and Verbal CommunicationAI-Enabled Tools Utilization

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk ManagementClinical PracticeDevice Safety AssessmentRegulatory ComplianceData Analysis

Soft Skills

Effective CommunicationTeam CollaborationProblem Solving

Tools & Technologies

Microsoft Office SuiteAI-Enabled Tools

Certifications & Qualifications

Medical LicenseBoard Certification

Industry Keywords

Medical DevicesProduct Risk ManagementIn Vitro DiagnosticsSoftware-as-a-Medical DeviceGlobal Medical Safety

About the role

Key responsibilities & impact

Evidence-based decision making for the severity of harms as a result of device-associated hazardous situations and associated probabilities of harm.
Documenting, explaining, and defending device risk assessment decisions made, and updating Product Risk Management (PRM) deliverables based on new evidence and inputs from cross-functional peers and stakeholders.
Representing Global Medical Safety at RMTs and quality event meetings convened for device assets.
Review and sign off on device Product Risk Assessments (PRA) and other PRM deliverables requiring medical input.
Leading standardization initiatives, including the development and maintenance of a global harms list.
Ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.
Ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
Meeting performance and risk metrics for device workflows that support strategic decision-making.
Supporting special projects and initiatives as needed.

Requirements

What you’ll need

Physician / Surgeon (MD, MBBS, DO, or equivalent), with at least 3 years of postgraduate training and 2 years of clinical practice experience is required.
At least 2 years of experience in the application of risk management to medical devices is required.
An active medical license and board certification in a relevant discipline is strongly preferred.
Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required.
Ability to rapidly assimilate and apply new information for device assets and regulations is required.
Demonstrated ability to leverage AI-enabled tools and technologies to improve decision-making, streamline work processes, and enhance business outcomes.
Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required.
Strong written and verbal communication skills are required.
Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required.

Benefits

Comp & perks

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