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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

The Medical Safety Officer provides medical safety leadership and clinical expertise for robotic surgery products. The role supports product risk-benefit assessment, post-market surveillance, risk management, regulatory interactions, product development, and safety-related decision-making across the product lifecycle.

Other Duties

Responsibilities include, but are not limited to:

• Assess product risk-benefit and provide medical input and review for risk management reports, health hazard evaluations, clinical evaluation reports, and product safety surveillance plans, including risk categorization of products and product families.

• Review and provide input on adverse events, complaints, and mass communications.

• Review internal and customer safety training materials.

• Provide input into the design and interpretation of safety-related studies and the results of product safety surveillance activities.

• Evaluate the medical impact of manufacturing issues.

• Provide clinical interpretation of post-market safety data, aggregate complaint data, individual case safety reports, and literature reports containing possible safety data.

• Provide medical safety expertise, oversight, and guidance related to product performance.

• Contribute to and periodically review product harms and hazards lists and the derivation of reportability criteria.

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

• Advise on failure investigations and provide medical opinions regarding reportability.

• Act as a subject matter expert during audits and interactions with regulatory bodies.

• Interface with customers and users to gather additional medical information or data required to support investigations.

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

• Review additional safety information for customers, when required, to help prevent repeat adverse events and complaints.

• Discuss adverse-event investigations and customer-experienced adverse events with healthcare professionals at their request.

• Monitor external sources and trends, including complaint and MDR/MDV trends and regulatory and market intelligence, and identify and escalate emerging issues.

• Serve as the medical representative in escalation processes involving field-action decisions and help evaluate the effectiveness of field safety corrective actions.

• Promote consistency in medical evaluations, Quality Review Board decisions, and overall product safety evaluations.

• Participate on cross-functional product development teams and advise on device safety and risk management.

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

• Deploy best practices in coordination with the Medical Device Chief Medical Office.

• Report to the Senior Safety Officer covering MedTech Surgery.

Required Qualifications

Education

Doctor of Medicine (MD), Doctor of Osteopathy (DO), or an equivalent designation such as MBChB.

Related Experience

• Minimum of five years of clinical experience after residency as a robotic surgeon in a specialty where robotics is actively used, such as general surgery or a subspecialty including bariatric or colorectal surgery, thoracic surgery, urology, or gynecology.

• Experience in risk evaluation and mitigation is preferred.

• Medical device and/or pharmaceutical industry experience is helpful.

• Clinical study or research experience is helpful.

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

• Knowledge of basic statistical techniques.

• Knowledge of basic epidemiological principles.

• Training and significant experience in surgical robotics.

• Knowledge of digital medicine and artificial intelligence as they relate to medical device integration is helpful.

Knowledge, Skills, and Abilities

• Knowledge of basic statistical techniques.

• Knowledge of basic epidemiological principles.

• Advanced Microsoft Excel skills.

• Training or significant experience in robotics.

Travel and People Management

Travel Required: Yes

Travel Percentage: 25%–30%

Type of Travel: Domestic (United States) and international

People Management Experience Required: No

Required Years of People Management Experience: Not applicable

Preferred Qualifications

Preferred Minimum Education: Doctor of Medicine (MD), Doctor of Osteopathy (DO), or an equivalent designation such as MBChB.

Preferred Area of Study: Surgical Specialty with application in soft tissue robotics (gen surg or sub specialty, thoracic, urology, gynecology)  with 5+ years clinical experience in robotics.

Preferred Related Industry Experience: Minimum of two years.

Preferred Knowledge, Skills, and Abilities: Board certification in Surgical specialty listed above.

Key Working Relationships

Internal: Medical Affairs, Clinical Affairs, Preclinical, Regulatory, Research and Development, and Quality.

External: Surgeons who use the company’s products.

Required Skills:

 

 

Preferred Skills:

Clinical Operations, Compliance Management, Compliance Risk, Data Gathering and Analysis, Developing Others, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Mentorship, Presentation Design, Quality Control (QC), Research Ethics, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing

 

 

The anticipated base pay range for this position is :

$229,000.00 - $395,600.00

Additional Description for Pay Transparency:

The applicable pay range for this position is $229,000 - $377,850

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).


This position is eligible to participate in the Company’s long-term incentive program.


Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

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