Device Safety Officer

Scorpion Therapeutics; Raritan (NJ); On-site; USD 160,000 - 230,000; Full time

Job summary

Johnson & Johnson's Innovative Medicine portfolio seeks a Device Safety Officer to lead risk management for medical devices across design, development, and post-market stages.

You will serve as the medical lead for device asset risk assessments, partner with Global Medical Safety in cross-functional Risk Management Teams, and drive global harms lists and regulatory compliance.

Qualifications

• MD, MBBS, DO, or equivalent with at least 3 years postgraduate training, 2+ years clinical practice, and 2+ years in medical device risk management.
• Active medical license and board certification preferred.
• Strong cross-disciplinary team leadership, rapid learning ability regarding device regulations, and effective communication skills.

Responsibilities

• Lead device risk management activities across design, development, and post-market stages.
• Serve as the primary medical point of accountability for device asset risk assessments.
• Represent Global Medical Safety in cross-functional Risk Management Teams.
• Review and approve risk assessments and PRM deliverables.
• Develop global harms lists and standardization initiatives.
• Maintain comprehensive knowledge of device assets including medical devices, diagnostics, and software.
• Support audits and inspections.
• Contribute to process improvements.

Skills

Device safety

Risk management

Cross-functional leadership

Regulatory knowledge

Communication skills

Education

MD/MBBS/DO or equivalent

Job description

Role: Device Safety Officer (DSO)

ensures medical safety excellence at the intersection of pharmaceuticals and medical devices within Johnson & Johnson's Innovative Medicine portfolio.

Responsibilities

• lead device risk management activities across design, development, and post-market stages
• serve as the primary medical point of accountability for device asset risk assessments
• represent Global Medical Safety in cross-functional Risk Management Teams
• review and approve risk assessments and PRM deliverables
• develop global harms lists and standardization initiatives
• maintain comprehensive knowledge of device assets including medical devices, diagnostics, and software
• support audits and inspections
• and contribute to process improvements.

Requirements

• MD, MBBS, DO, or equivalent with at least 3 years postgraduate training, 2+ years clinical practice, and 2+ years in medical device risk management
• active medical license and board certification preferred
• strong cross-disciplinary team leadership, rapid learning ability regarding device regulations, and effective communication skills

Preferred skills

clinical operations, compliance, risk management, and safety investigations.

High-Value

focus on medical devices, diagnostics, software-as-a-medical device, risk assessment, global regulations (EU MDR/IVDR, FDA 21 CFR Part 4, ISO standards).

Work Setup

multiple U.S. sites; specific travel requirements not detailed but likely demand for cross-functional collaboration.