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 medical input.

·        Leading standardization initiatives, including the development and maintenance of a global harms list.

·        Ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.

·        Ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.

·        Meeting performance and risk metrics for device workflows that support strategic decision-making.

·        Supporting special projects and initiatives as needed.

Qualifications:

·        Physician / Surgeon (MD, MBBS, DO, or equivalent), with at least 3 years of postgraduate training and 2 years of clinical practice experience is required.

·        At least 2 years of experience in the application of risk management to medical devices is required.

·        An active medical license and board certification in a relevant discipline is strongly preferred.

·        Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required.

·        Ability to rapidly assimilate and apply new information for device assets and regulations is required.

·       Demonstrated ability to leverage AI-enabled tools and technologies to improve decision-making, streamline work processes, and enhance business outcomes.

·        Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required.

·        Strong written and verbal communication skills are required.

·        Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: