Medical Safety Officer - Robotics and Digital (RAD)

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function:
Product Safety

Job Sub Function:
Product Safety Risk Management MD

Job Category:
People Leader

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

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.

Other Duties

Responsibilities include, but are not limited to:


* 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 c...