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Director, Medical Safety Officer (MSO) – Robotics, Digital and Advanced Imaging - 2306152566W

Description

Medical Device Business Services, Inc., part of Johnson & Johnson MedTech, is currently recruiting for a Medical Safety Officer (MSO) – Robotics, Digital and Advanced Imaging located in Santa Clara/Redwood City, 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.

J&J MedTech is the medical device division of J&J, including surgical devices marketed under the Ethicon Brand. The Robotics division encompasses the Ottava soft tissue robotics program (currently in development), the Monarch endoluminal program which includes in market Bronchoscopy and Urology systems, and the Digital and Advanced Imaging platforms.

The Medical Safety Officer role is to provide medical safety stewardship for devices in the portfolio. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. In the post-market space, the Medical Safety Officer is an active member of a cross functional team, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal in the field. The MSO plays a pivotal role in evaluating customer/user risk and in assessing the actual or potential impact of product performance issues on patient safety, and thus plays a role in product launches. 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 in the design and development space, acting as an imbedded member of the team in the innovation process, engaging with R&D and quality engineering to drive the safe and effective development of products in the robotics portfolio.

The Medical Safety Officer will have primary responsibility for Robotics, Digital Solutions and Advanced Imaging

Responsibilities include, but are not limited to the following:

• Assess product risk-benefit and provide medical input/review to:

• Risk Management Reports

• Health Hazards Evaluations

• Clinical Evaluation Reports

• Product Safety Surveillance Plans (SSPs), including risk categorization of product/product families

• 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

• Evaluation of medical impact of manufacturing issues

• Clinical interpretation of:

• Post-marketing safety data

• Aggregate complaint data

• Individual case safety reports

• Literature reports with possible safety data

• Provide medical safety expertise, oversight, and guidance as it relates to the performance of products

• Contribute to and periodically review the definition of a product’s harms and hazards list and derivations of criteria for reportability

• Review and approve (from a medical safety perspective) appropriate reports and filings

• Advise on failure investigations and provide medical opinion when deciding on reportability

• Act as subject matter expert in audit and other regulatory body interactions

• Interface with customers/users to gather additional medical information/data when required to support investigations

• Review responses to, for example, regulatory bodies, clinicians, and patients when safety issues are involved

• When required, review additional safety-related information to customers to prevent repeat adverse events and complaints

• The MSO will discuss with healthcare professionals (at their request) AE investigations as well as discussion of AEs that the customer experienced.

• Monitor external sources/trends and identify and escalate emerging issues. These include (but are not limited to):

• complaint & MDR/MDV trends

• regulatory & market trends/intelligence

• Be the medical representative within the escalation 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

• Participate with cross functional product development teams, advising on the safety/risk management of devices in development.

• Ensure appropriate metrics are used to assess adequacy of patient safety related processes.

• Deploy best practice in co-ordination with MD CMO

• Reports to Senior Safety Officer covering Robotics and Digital.

Qualifications

Requirements:

• Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree, such as MBChB

• Minimum of 5 years’ clinical experience (after completion of residency) as a robotic surgeon in a specialty in which robotics is actively used i.e., general surgery (or subspecialties such as bariatric, colorectal etc.), thoracic surgery, urology or gynecology is required.

• Experience in risk evaluation and mitigation is preferred.

• Medical device and/or pharmaceutical industry experience is helpful

• Clinical study/research experience is helpful

• Experience of interfacing with senior leadership within a global healthcare company is preferred

• A knowledge of basic statistical techniques

• A knowledge of basic epidemiological principles

• Training and significant experience in Surgical Robotics

The anticipated base pay range for this position is $186,000 to $322,000.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

Primary Location NA-US-California-Santa Clara

Other Locations NA-US-California-Redwood City

Organization Medical Device Business Services, Inc (6029)

Job Function Drug & Product Safety Science

Req ID: 2306152566W