Medical Safety Officer - Robotics and Digital (RAD)

Job description

Job responsibilities

• Assess product risk-benefit and provide medical input and review for risk management reports, health hazard evaluations, clinical evaluation reports, and product safety surveillance plans, including risk categorization…
• Review and provide input on adverse events, complaints, and mass communications.
• Review internal and customer safety training materials.
• Provide input into the design and interpretation of safety-related studies and the results of product safety surveillance activities.
• Evaluate the medical impact of manufacturing issues.
• Provide clinical interpretation of post-market safety data, aggregate complaint data, individual case safety reports, and literature reports containing possible safety data.
• Provide medical safety expertise, oversight, and guidance related to product performance.
• Contribute to and periodically review product harms and hazards lists and the derivation of reportability criteria.

Job requirements

• Minimum of five years of clinical experience after residency as a robotic surgeon in a specialty where robotics is actively used, such as general surgery or a subspecialty including bariatric or colorectal surgery,…
• Experience in risk evaluation and mitigation is preferred.
• Medical device and/or pharmaceutical industry experience is helpful.
• Clinical study or research experience is helpful.
• Experience interfacing with senior leadership within a global healthcare company is preferred.
• Knowledge of basic statistical techniques.
• Knowledge of basic epidemiological principles.
• Training and significant experience in surgical robotics.