Senior Manager Post-Market Surveillance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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: Quality Job Sub Function: Customer/Commercial Quality Job Category: People Leader All Job Posting Locations: Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for a Senior Manager Post-Market Surveillance! This position can be located in Cincinnati, OH, Danvers, MA, Irvine, CA or Raritan, NJ. Role focus: Accountable for the end-to-end design, performance and advancement of a defined global Post Market Surveillance processes. This role owns the process strategy, translation of business requirements into technical solutions, including accountability for governance of vendor-supported complaint and post-market quality services. Position Summary: The Senior Manager, Post-Market Surveillance Governance is responsible for the global governance, effectiveness, and continuous improvement of MedTech Post-Market Surveillance processes, systems, data, analytics, and reporting. The role leads the enterprise Post-Market Surveillance operating model across MedTech Business Units , ensuring regulatory readiness, consistent execution, data integrity, timely signal detection, and delivery of Post-Market Surveillance plans, reports, and related regulatory documentation. This leader will be responsible for the Business technical systems requirements & delivery for all quality system applications and digital solutions to support process execution. The role also provides governance and operational oversight for vendors supporting complaint management, Post-Market Surveillance, analytics, and related post-market quality services. This accountability includes translating quality and business requirements into supplier expectations, monitoring service, quality, compliance, capacity, and cost performance, and driving timely escalation, corrective action, and value creation. The position partners across franchises, Medical Safety, Regulatory, Clinical, Engineering, Quality, Global Services, Procurement, Finance, Information Technology, and external suppliers to deliver compliant, scalable, efficient, and insight-driven post-market outcomes. Key Responsibilities: In accordance with all applicable federal, state, and local laws and regulations and Johnson & Johnson procedures and guidelines, this position, under limited supervision: Provide global governance for Post-Market Surveillance procedures, systems, data, analytics, and reporting, including strategic planning and impact assessments for emerging regulations, standards, and health authority expectations. Lead the MedTech Post-Market Surveillance operating model across franchises, promoting consistent, scalable, and risk-based execution for complaint trending, signal detection, Post-Market Surveillance plans, Post-Market Surveillance reports, and related regulatory documentation. Interpret Post-Market Surveillance requirements and translate them into practical policies, procedures, systems, controls, training, and implementation plans that support patient safety, regulatory compliance, proactive risk management, and cost efficiency. Oversee methods for identifying, analyzing, evaluating, documenting, and escalating potential product signals, including complaint-rate trends, adverse-event rates, part usage, and other product-performance indicators. Support data scientists and other assigned team members in developing, maintaining, and advancing analytical methods, algorithms, digital tools, systems, and responsible artificial intelligence capabilities used by Post-Market Surveillance and vigilance teams. Ensure appropriate governance of data quality, analytical methods, statistical rationales, validation, documentation, change control, and technology sustainability. Drive continuous improvement and harmonization of global Post-Market Surveillance processes through automation, standardized data models, reporting tools, digital enablement, and cross-business adoption of best practices. Partner with franchise, Medical Safety, Regulatory, Clinical, Engineering, Quality, and executive stakeholders on surveillance priorities, product signals, new product launches, acquisitions, integrations, corrective and preventive actions, and ad hoc data-analysis needs. Support applicable Post-Market Surveillance submissions, health authority responses, audits, inspections, compliance reviews, and gap assessments. Provide governance and operational oversight for vendors supporting complaint management, Post-Market Surveillance, analytics, and related post-market quality services. Translate business, quality, privacy, information-security, and regulatory requirements into clear vendor scopes, service levels, quality expectations, performance measures, escalation pathways, and governance routines. Monitor vendor performance using service, quality, compliance, timeliness, capacity, cost, and process-health indicators; identify trends, escalate material risks, and drive corrective and continuous improvement actions. <