Device Safety Officer (MedTech)

Location: Raritan, New Jersey, United States of America. Full-time, onsite role. Other posting locations include Horsham, Pennsylvania, and Titusville, New Jersey.

Anticipated base pay range: $199,000–$343,850 per year.

Company

Johnson & Johnson MedTech develops healthcare solutions spanning medical devices and innovative medicine.

What you will do

• Act as the primary medical safety accountability point for device risk management teams across assigned programs and products.
• Assess the severity and probability of harm from device-associated hazardous situations using available evidence.
• Document, explain, and defend device risk decisions, and update product risk management deliverables as new evidence becomes available.
• Review and sign off on product risk assessments and other deliverables requiring medical input.
• Represent Global Medical Safety in risk management teams and quality event meetings.
• Lead standardization initiatives, maintain a global harms list, and support audits, inspections, special projects, and device process improvements.

Requirements

• Physician or surgeon qualification: MD, MBBS, DO, or equivalent.
• At least three years of postgraduate training and two years of clinical practice experience.
• At least two years of experience applying risk management to medical devices.
• Ability to work onsite in the United States and drive cross-disciplinary, highly matrixed teams toward safety and compliance objectives.
• Ability to apply global device regulations and standards, including EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, and ISO 14155, ISO 14971, and ISO 20916.
• Strong written and verbal communication, presentation, information assimilation, and Microsoft Office skills.

Nice to have

• Active medical license and board certification in a relevant discipline.
• Experience with clinical operations, compliance, safety investigations, surveillance, research ethics, and medicines and device development regulation.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Eligibility for a consolidated retirement plan, pension, savings plan, and 401(k).
• Participation in a long-term incentive program.
• Paid vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.