Medical SAFETY Officer, Vision

Job Summary

The MSO role will provide medical safety stewardship for J&J Vision products, collaborating in assessing potential safety signals and serving as a key member of cross‑functional teams. The MSO executes the Medical Safety Organization’s strategy, implements risk management programs, and builds relationships across Medical Affairs, R&D, Quality, Regulatory, Clinical, and Epidemiology to proactively manage patient risk throughout the product lifecycle.

• Collaborate in‑person with Medical Affairs, R&D, Clinical, Regulatory, and senior leadership.
• Chair the Safety Management Team (SMT) and oversee its functions.
• Conduct First‑in‑Human triage meetings.
• Oversee safety‑related aspects of devices, including benefit/risk assessment, Risk Management Reports, Product Issue assessments, and Health Risk Evaluations.
• Review and provide input into Clinical Evaluation Reports on benefit‑risk issues, Safety Surveillance Plans, and risk categorization of product families.
• Represent Medical Safety in product reviews during development, providing medical input on Design and Development plans and identifying SMT members.
• Contribute to Risk Management Plans, Risk Management Reports, and Post‑Market Surveillance Plans; review and approve Final Labeling content related to risk mitigation.
• Oversee clinical studies focused on identifying potential safety signals, reviewing protocols, Safety Management Plans, Investigator Brochures, data, safety reports, and final study reports.
• Interpret post‑marketing safety data, complaint and individual case safety reports, literature reports, and provide input on mitigations, labeling changes, and safety training.
• Evaluate medical impact of manufacturing and design issues and provide guidance on performance of products.
• Monitor external sources—complaint trends, regulatory trends, literature—and identify emerging issues.
• Advise on adverse event investigations, field safety corrective actions, and reportability decisions; ensure consistent medical evaluations at Risk Management Boards.
• Act as subject‑matter expert in audit and regulatory interactions, review and approve medical safety reports and filings, and coordinate with Regional Safety Officers.
• Participate in due‑diligence activities for potential acquisitions.

• Required: Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent with a therapeutic specialty in an academic or hospital environment; completion of an ophthalmology residency; minimum 3 years clinical or research experience or related training; basic knowledge of AI tools, Microsoft Office, basic statistical and epidemiological principles.
• Preferred: Fellowship in corneal or cataract surgery, board certification; experience in risk evaluation and mitigation; medical device or pharmaceutical industry experience; knowledge of local and international medical device regulations; advanced statistical knowledge; global senior‑leadership interfacing experience.

Location:

Irvine, California, United States of America. Requires up to 25% travel based on business needs.

• Clinical Operations
• Compliance Management
• Compliance Risk
• Consulting
• Design Mindset
• Developing Others
• Leadership
• Medicines and Device Development and Regulation
• Operational Excellence
• Quality Control (QC)
• Research Ethics
• Risk Management
• Safety Investigations
• Safety‑Oriented
• Serious Adverse Event Reporting
• Standard Operating Procedure (SOP)
• Succession Planning
• Surveillance

• Clinical Operations
• Compliance Management
• Compliance Risk
• Consulting
• Design Mindset
• Developing Others
• Leadership
• Medicines and Device Development and Regulation
• Operational Excellence
• Quality Control (QC)
• Research Ethics
• Risk Management
• Safety Investigations
• Safety‑Oriented
• Serious Adverse Event Reporting
• Standard Operating Procedure (SOP)
• Succession Planning
• Surveillance

Base pay range: $199,000 – $342,700 annually. Eligible for a performance bonus and the long‑term incentive program. Benefit package includes medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, a consolidated retirement plan (401(k)), vacation up to 120 hours per calendar year, sick time up to 40 hours per calendar year (56 hours for Washington State employees), holiday pay, floating holidays, and additional leave for work, personal and family time.

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, protected veteran status, or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.