Medical Safety Officer

Medical Devices & Diagnostics Global Services, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Medical Safety Officer, located in Irvine, CA.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide.  Together, we are working to shape the future of health through differentiated products and services.

The Medical Safety Officer (MSO) role will have primary responsibility for Biosense Webster, Inc. (BWI) and will provide medical safety stewardship for Medical Device (MD) products.  Although a medically independent voice is key, collaboration in assessing potential safety signals is expected.  This individual will be an active member of a diverse team, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for an MD product.  Execute on the Medical Safety Organization’s strategy, by implementing programs and leading in the strategic priority areas as defined by the Chief Medical Officer (CMO).

The MSO will build clear and positive relationships between R&D, Quality, Regulatory, Clinical, Epidemiology and Safety sciences and Safety process and groups to allow for proactive and flexible risk management system.  Serve as a subject matter authority in the therapeutic area and patient risk management throughout the product lifecycle, from new product development, to launch and commercial life.

The MSO will play a pivotal role in evaluating customer/user risk and in assessing the actual or potential impact of product performance issues on patient safety.  The reactive elements of the role (addressing Quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities, which should be taken to minimize potential risk to patients.  Further, the MSO must be a trusted partner in the innovation process, engaging with R&D and quality engineering to drive Medical Devices and Diagnostics (MD&D’s) patient-centered innovation process.

Primary Responsibilities:

• Assess product risk-benefit and offer medical input/review to Risk Management Reports, Product Issue assessment/ Health Hazards Evaluations, Clinical Evaluation Reports, Product Safety Surveillance Plans (SSPs), including risk categorization of product/product families.  Review and provide input on mitigations, labeling and internal and customer safety training materials directed to minimize patient risk and improve outcomes, adverse events, complaints and mass communications.
• Clinical interpretation of post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with possible safety data.
• Input into design and interpretation of safety-related studies, and results of any SSP activities
• Represent Medical Safety in various product reviews during development.
• Evaluation of medical impact of manufacturing and design issues.
• Oversight and guidance, as it relates to the performance and Medical Safety of products.
• Monitor external sources/trends and identify and call out emerging issues.  These include, but are not limited to, complaint and Medical Device Regulation (MDR)/Medical Device Vigilance (MDV) trends, regulatory and market trends/intelligence, literature and scientific publications.
• Advise on failure investigations and provide medical opinion when deciding on reportability.
• Work with customers/users to gather additional medical information/ data when required to support investigations.
• Review additional safety-related information to customers to prevent repeat adverse events and complaints.
• Discuss with healthcare professionals (at their request) Adverse Event (AE) investigations as well as discussion of AEs that the customer experienced.
• Be the medical representative within the review process when making decisions on field actions and help evaluate the effectiveness of field safety corrective actions.
• Ensure consistency in medical evaluations, Quality Review Board decisions and overall Safety evaluations of products.
• Deploy standard practices in co-ordination with MD CMO.
• Ensure appropriate metrics are used to assess adequacy of patient safety related processes.
• Contribute to and periodically review the definition of a product’s harms and hazards list and derivations of criteria for reportability.
• Act as subject-matter-expert in audit and other regulatory body interactions.
• Review and approve (from a medical safety perspective) appropriate reports and filings.
• Review responses to, for example, regulatory bodies, clinicians and patients when safety issues are involved.
• Coordinate with Regional Safety Officers to ensure timely coordination of information.

• Doctor of Medicine (MD), Doctor of Osteopathy (DO) or equivalent degree is required.
• A minimum of 3 years of clinical or research experience is required.
• Relevant experience or specific training in a Cardiovascular specialty is required.
• Experience in the following surgical specialties preferred: Electrophysiology, Interventional Cardiology or Cardiology.
• Experience in the healthcare industry (Pharmaceutical, Medical Device and/or other healthcare organization) is preferred.
• Knowledge of local and international Medical Device regulations preferred.
• Knowledge of basic statistical techniques required.
• Knowledge of basic epidemiological principles required.
• Knowledge of pre-clinical or clinical research basic concepts required.
• Experience in risk evaluation and mitigation is preferred.
• Clinical study/research experience is preferred.
• Advanced statistical knowledge (e.g. multivariate data analysis) is preferred.
• Experience with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
• Experience working with senior leadership within a global healthcare company is preferred.
• Must have excellent verbal and written communication skills.
• The ability to influence decision-making with internal and external stakeholders is required.
• This position will require up to 10% travel.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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