Device Safety Officer

About the role

The Device Safety Officer (DSO) ensures medical safety excellence at the intersection of pharmaceuticals and medical devices. Reporting to Global Medical Safety, the DSO is the single point of accountability for medical assessment of device risk throughout design, development, and post‑market phases.

Key responsibilities

• Make evidence‑based decisions on severity of harms and probabilities for device‑associated hazardous situations.
• Document, explain, and defend device risk assessment decisions and update Product Risk Management deliverables.
• Represent Global Medical Safety on Risk Management Teams and quality event meetings.
• Review and sign off on device Product Risk Assessments and other deliverables requiring medical input.
• Lead standardisation initiatives, including development of a global harms list.
• Maintain a comprehensive knowledge base of in‑scope device assets across the portfolio.
• Ensure compliant resolution of competing priorities across multiple stakeholders.
• Support special projects and initiatives to streamline device processes.

Required profile

• Physician or Surgeon (MD, MBBS, DO or equivalent) with at least 3 years postgraduate training and 2 years clinical practice.
• Minimum 2 years experience applying risk management to medical devices.
• Active medical license and board certification (strongly preferred).
• Proven ability to drive cross‑disciplinary, matrixed teams to meet safety and compliance objectives.
• Strong written and verbal communication skills.

Required skills

• Microsoft Office Suite (Word, Excel, PowerPoint).
• Use of AI‑enabled tools to improve decision‑making and streamline processes.
• Knowledge of global device regulations and standards (EU MDR/IVDR, FDA 21 CFR Part 4, ISO 14155, 14971, 20916).

What we offer

• Base salary range $199,000 – $343,850 per year.
• Eligibility for company retirement (pension) and 401(k) plans.
• Participation in long‑term incentive program.
• Generous paid time off including vacation, sick leave, holidays, parental and bereavement leave.
• Additional volunteer, caregiver, and military spouse leave.