Medical Safety Officer - Robotics and Digital (RAD)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

The Medical Safety Officer provides medical safety leadership and clinical expertise for robotic surgery products. The role supports product risk-benefit assessment, post-market surveillance, risk management, regulatory interactions, product development, and safety-related decision-making across the product lifecycle.

• →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 of products and product families.

• →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.

• →Review and approve appropriate reports and filings from a medical safety perspective.

• →Advise on failure investigations and provide medical opinions regarding reportability.

• →Act as a subject matter expert during audits and interactions with regulatory bodies.

• →Interface with customers and users to gather additional medical information or data required to support investigations.

• →Review responses to regulatory bodies, clinicians, and patients when safety issues are involved.

• →Review additional safety information for customers, when required, to help prevent repeat adverse events and complaints.

• →Discuss adverse-event investigations and customer-experienced adverse events with healthcare professionals at their request.

• →Monitor external sources and trends, including complaint and MDR/MDV trends and regulatory and market intelligence, and identify and escalate emerging issues.

• →Serve as the medical representative in escalation processes involving field-action decisions and help evaluate the effectiveness of field safety corrective actions.

• →Promote consistency in medical evaluations, Quality Review Board decisions, and overall product safety evaluations.

• →Participate on cross-functional product development teams and advise on device safety and risk management.

• →Ensure appropriate metrics are used to assess the adequacy of patient-safety processes.

• →Deploy best practices in coordination with the Medical Device Chief Medical Office.

• →Report to the Senior Safety Officer covering MedTech Surgery.

Doctor of Medicine (MD), Doctor of Osteopathy (DO), or an equivalent designation such as MBChB.

• 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, thoracic surgery, urology, or gynecology.

• 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.

• Knowledge of digital medicine and artificial intelligence as they relate to medical device integration is helpful.

• Knowledge of basic statistical techniques.

• Knowledge of basic epidemiological principles.

• Advanced Microsoft Excel skills.

• Training or significant experience in robotics.

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