Director, Medical Safety Officer, Biosurgery and Endomechanical

$194,000 - $334,650/Yr

Johnson & Johnson - Raritan, NJ

Full-time - Senior

Raritan, NJ

Chemical Manufacturing

About the position

The Director, Medical Safety Officer for Biosurgery and Endomechanical at Johnson & Johnson is responsible for providing medical safety stewardship for MedTech Surgery products. This role involves collaboration with cross-functional teams to assess safety signals, manage risks, and ensure patient safety throughout the product lifecycle. The MSO will engage with various departments, including Medical Affairs, R&D, and Quality, to implement safety strategies and drive patient-centered innovation. The position requires a strong medical background, particularly in robotic surgery, and a proactive approach to risk management.

Responsibilities

• Assess product risk-benefit and provide medical input/review to Risk Management Reports, Health Hazards Evaluations, Clinical Evaluation Reports, and Product Safety Surveillance Plans.
• Review and provide input on Adverse Events, complaints, and mass communications.
• Review internal and customer safety training materials.
• Input into design and interpretation of safety-related studies, and results of any SSP activities.
• Evaluate the medical impact of manufacturing issues and clinical interpretation of post-marketing safety data.
• Provide medical safety expertise, oversight, and guidance related to product performance.
• Contribute to and periodically review the definition of a product's harms and hazards list.
• Review and approve reports and filings from a medical safety perspective.
• Advise on failure investigations and provide medical opinion on reportability.
• Act as subject matter expert in audit and regulatory body interactions.
• Interface with customers/users to gather additional medical information/data for investigations.
• Monitor external sources/trends and identify and escalate emerging issues.
• Ensure consistency in medical evaluations and overall safety evaluations of products.
• Participate with cross-functional product development teams, advising on safety/risk management of devices in development.

Requirements

• Doctor of Medicine (MD), Doctor of Osteopathy (DO) designation or equivalent.
• Minimum of 5 years' clinical experience as a robotic surgeon in a relevant specialty.
• Experience in risk evaluation and mitigation is preferred.
• Medical device and/or pharmaceutical industry experience is helpful.
• Clinical study/research experience is helpful.
• Experience interfacing with senior leadership within a global healthcare company is preferred.
• Knowledge of basic statistical techniques and epidemiological principles.
• Training and significant experience in Surgical Robotics.
• Knowledge of Digital medicine/Artificial Intelligence as it relates to medical device integration is helpful.
• Advanced Microsoft Excel skills.

Nice-to-haves

• Experience in risk evaluation and mitigation.
• Medical device and/or pharmaceutical industry experience.
• Clinical study/research experience.
• Experience interfacing with senior leadership within a global healthcare company.

Benefits

• Health insurance
• Savings plan
• Pension plan
• Disability plan
• Long term incentives
• Vacation pay
• Sick time
• Holiday pay
• Work, personal and family time off