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EDUCATION:

• Bachelors degree in a Health Sciences or Engineering discipline is required

PURPOSE:

The Device Safety Associate (DSA) is a specialized role that ensures operational safety excellence at the intersection of pharmaceuticals and medical devices. As a member of the Global Medical Safety Operations group in J&J Innovative Medicine, they are responsible for ensuring that safety processes for in-scope device assets are compliantly executed and maintained across all lifecycle stages.
The DSA 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 13485/14971/20916.
Within this hybrid regulatory and compliance framework, the DSA is expected to bring together physicians, scientists, and engineers of diverse backgrounds in a highly matrixed environment to execute complex operational tasks and solve challenges in a collaborative and professional manner.
In addition, the DSA will serve as a subject matter expert in their role for both internal consultations and audits/inspections, and participate in special projects and initiatives to streamline and optimize device processes and key metrics.

YOU WILL BE RESPONSIBLE FOR:

• 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.
• analyzing safety responsibilities for each device asset to support internal vs. external resourcing decisions, and work with cross-functional teams to ensure compliant task disposition and execution in a timely manner.
• leading cross-functional meetings to execute safety-specific deliverables for assigned device assets, beginning at design time and throughout reporting and risk management activities.
• creating and maintaining procedural documents that drive compliant, optimized workflows for device assets within the pharmaceuticals portfolio.
• ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
• maintaining performance and risk metrics for device workflows that support strategic decision-making.
• supporting special projects and initiatives as needed.