Device Safety Officer

Scorpion Therapeutics; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson is seeking a Device Safety Officer (DSO) to ensure medical safety excellence at the intersection of pharmaceuticals and medical devices within the Innovative Medicine portfolio.

Locations include Horsham, PA; Raritan and Titusville, NJ, with cross-site collaboration flexibility. The role requires MD/MBBS/DO or equivalent, 3+ years postgraduate training, and 2+ years in device risk management, with leadership and regulatory expertise.

Qualifications

• MD, MBBS, DO, or equivalent with 3+ years postgraduate training and 2+ years clinical practice.
• At least 2 years in medical device risk management.
• Active medical license and board certification preferred.
• Strong ability to lead matrixed teams and assimilate new information.
• Ability to leverage AI tools in safety activities.
• Excellent communication skills and proficiency with MS Office.

Responsibilities

• Lead medical risk assessments across device design, development, and post-market.
• Serve as the primary Medical Safety point in cross-functional Risk Management Teams.
• Ensure compliance with global regulations (EU MDR, FDA 21 CFR Part 4, ISO standards).
• Review and approve Device Risk Assessments.
• Develop and maintain global harms lists.
• Represent safety in audits and inspections.

Skills

Medical risk mgmt

Leadership

AI tools

Regulatory compliance

Communication

MS Office

Education

MD/MBBS/DO or equivalent

Board certification preferred

Tools

Microsoft Office

Job description

Role

Device Safety Officer (DSO) ensuring medical safety excellence at the intersection of pharmaceuticals and medical devices within Johnson & Johnson's Innovative Medicine portfolio.

Responsibilities

• lead medical risk assessments across device design, development, and post-market phases;
• serve as the primary Medical Safety point in cross-functional Risk Management Teams;
• ensure compliance with global regulations such as EU MDR, FDA 21 CFR Part 4, and ISO standards;
• review and approve Device Risk Assessments;
• develop and maintain global harms lists;
• and represent safety in audits and inspections.

Qualifications

• MD, MBBS, DO, or equivalent with a minimum of 3 years postgraduate training and 2 years clinical practice;
• at least 2 years in medical device risk management;
• active medical license and board certification preferred;
• strong ability to lead matrixed teams, quickly assimilate new information, and leverage AI tools;
• excellent communication skills;
• proficiency in Microsoft Office.

High-Value

• focus on medical devices, in vitro diagnostics, and software as a medical device, across design, regulatory, and post-market lifecycle, with emphasis on risk management, safety assessments, and compliance.

Work Setup

locations in Horsham, PA; Raritan and Titusville, NJ, with flexibility for cross-site collaboration.