Global Device Safety Lead

Johnson & Johnson Innovative Medicine; Titusville (NJ); On-site; USD 199,000 - 343,850; Full time

Benefits offered by this job

Long-term incentive program

401(k) plan

Vacation and leave benefits

Pension plan

Job summary

Johnson & Johnson Innovative Medicine is seeking a Device Safety Officer (DSO) to ensure medical safety excellence across our pharmaceutical and medical device portfolio, from design through post‑market. With deep expertise in device risk management, the DSO acts as the primary medical lead for cross‑functional risk teams and global safety regulatory compliance.

The role requires staying current with EU MDR/IVDR, FDA 21 CFR Part 4, ISO standards, and strong communication to summarize complex

Qualifications

• MD/DO/MBBS or equivalent with 3+ years postgraduate training and 2+ years clinical practice.
• Active medical license and board certification preferred.
• Experience applying risk management to medical devices.
• Ability to drive cross-disciplinary, matrixed teams to safety objectives.

Responsibilities

• Lead device risk management decisions and defend risk assessments.
• Represent Global Medical Safety at cross-functional risk teams.
• Review and sign off on device Product Risk Assessments and PRM deliverables.
• Lead standardization initiatives, including global harms list.
• Maintain knowledge base of in-scope device assets and programs.
• Ensure timely resolution of competing priorities across programs.
• Meet performance and risk metrics for device workflows.

Skills

Medical license

Board certification

Cross-functional leadership

Regulatory knowledge

Communication skills

AI-enabled tools

SOP/QA

Education

MD/MBBS/DO or equivalent

Tools

MS Office

Job description

Johnson & Johnson Innovative Medicine is seeking a Device Safety Officer (DSO) to ensure medical safety excellence across our pharmaceutical and medical device portfolio, from design through post‑market. With deep expertise in device risk management, the DSO acts as the primary medical lead for cross‑functional risk teams and global safety regulatory compliance.

The role requires staying current with EU MDR/IVDR, FDA 21 CFR Part 4, ISO standards, and strong communication to summarize complex