Device Safety Officer

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

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:
Scientific/Technology

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Purpose:

The Device Safety Officer (DSO) is a specialized role that ensures medical safety excellence at the intersection of pharmaceuticals and medical devices.

Utilizing their medical / surgical training and deep domain expertise in device risk management, the DSO is the single point of accountability for the medical assessment of device asset risk throughout the design, development, and post-market lifecycle for assigned programs and products.

As a member of the J&J Innovative Medicine Safety Management Team (SMT) for assigned programs and products, the DSO represents Global Medical Safety as the primary point of accountability for cross-functional device Risk Management Teams (RMT).

The DSO is expected to utilize and remain current in their knowledge of global device regulations, standards, and guidance to support this mission within a pharmaceutical-led portfolio, including but not limited to EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, and ISO 14155/14971/20916.

In addition, the DSO will serve as a subject matter expert in their role for internal consultations, audits/inspections, and other proceedings, and will participate in special projects and initiatives to streamline and optimize device processes and meet key performance metrics.

You will be responsible for:

• Evidence-based decision making for the severity of harms as a result of device-associated hazardous situations and associated probabilities of harm.

• Documenting, explaining, and defending device risk assessment decisions made, and updating Product Risk Management (PRM) deliverables based on new evidence and inputs from cross-functional peers and stakeholders.

• Representing Global Medical Safety at RMTs and quality event meetings convened for device assets.

• Review and sign off on device Product Risk Assessments (PRA) and other PRM deliverables requiring me...