Device Safety Lead: Medical Risk & Compliance Expert

Johnson Johnson; Raritan (NJ); On-site; USD 199,000 - 344,000; Full time

Benefits offered by this job

Vacation time

Sick leave

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson seeks a Device Safety Officer to lead medical device risk management across design, development, and post-market life cycles.

You will represent Global Medical Safety in cross-functional teams, apply global regulations (EU MDR/IVDR, FDA 21 CFR Part 4, ISO 14155/14971/20916), and drive safety excellence. An MD/DO with 3+ years postgrad training and 2+ years device risk experience is required; board certification preferred.

Qualifications

• MD/MBBS/DO with 3+ years postgraduate training and 2+ years of clinical practice
• At least 2 years of experience applying risk management to medical devices
• Active medical license and board certification in a relevant discipline strongly preferred
• Ability to drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives
• Ability to assimilate new information for device assets and regulations
• Strong writing and presentation skills for diverse audiences
• Proficiency with MS Office Suite for documentation and reporting

Responsibilities

• Decide on the severity of harms from device-related hazards and document risk assessments
• Sign off on device Product Risk Assessments and other PRM deliverables
• Represent Global Medical Safety at RMTs and quality event meetings
• Lead standardization initiatives and global harms list maintenance
• Maintain knowledge base across device assets and programs
• Support audits, inspections, and cross-functional reviews
• Meet performance and risk metrics for device workflows
• Contribute to special projects to streamline device processes

Skills

Cross-functional leadership

Medical writing

Regulatory knowledge

Communication skills

MS Office

Education

MD/MBBS/DO or equivalent

Board certification preferred

Tools

MS Office

Job description

Johnson & Johnson seeks a Device Safety Officer to lead medical device risk management across design, development, and post-market life cycles.

You will represent Global Medical Safety in cross-functional teams, apply global regulations (EU MDR/IVDR, FDA 21 CFR Part 4, ISO 14155/14971/20916), and drive safety excellence. An MD/DO with 3+ years postgrad training and 2+ years device risk experience is required; board certification preferred.