Medical Safety Officer - Electrophysiology

Medical Safety Officer - Electrophysiology

Johnson & Johnson is seeking a Medical Safety Officer (MSO) to provide medical safety stewardship for Medical Device (MD) products. The role is based in Irvine, CA, or Plymouth, MN, and involves collaboration with R&D, Quality, Regulatory, Clinical, Medical Affairs, Epidemiology, and Safety Sciences.

Irvine, California or Plymouth, Minnesota.

• Assess product risk-benefit and provide medical input/review for Risk Management Reports, Product Issue assessments, Clinical Evaluation Reports, and Product Safety Surveillance Plans.
• Interpret post-marketing safety data, adverse events, and complaint data and support safety-related studies.
• Represent Medical Safety in product reviews during development and evaluate medical impact of manufacturing and design issues.
• Monitor external sources/trends and call out emerging issues, including complaint, regulatory, and market trends.
• Advise on failure investigations and provide medical opinion on reportability.
• Work with customers/users to gather additional medical information when required to support investigations.
• Ensure consistency in medical evaluations and Safety evaluations of products and deploy standard practices in coordination with MD CMO.

• Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree.
• Minimum of 3 years clinical or research experience.
• Relevant experience or specific training in Cardiovascular field.
• Knowledge of basic statistical techniques and epidemiological principles.

• Specialty in Electrophysiology, Interventional Cardiology, Cardiology, or Interventional Radiology.
• Experience in risk evaluation and mitigation.
• Medical device and/or pharmaceutical industry experience in Health Care and/or device industry.
• Advanced statistical knowledge (e.g. multivariate data analysis).
• Knowledge of local and international Medical Device regulations.

Base salary range: $199,000 – $343,000 per year. Eligible for an annual performance bonus and long‑term incentive program.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability status, or protected veteran status.