Senior Manager, Global Post-Market Surveillance

Johnson & Johnson; Cincinnati (OH); On-site; USD 122,000 - 213,000; Full time

Job summary

Johnson & Johnson seeks a Senior Manager, Post-Market Surveillance Governance to lead global PMS processes, systems, and data across MedTech. You will collaborate with franchises, Medical Safety, Regulatory, Clinical, and IT to ensure regulatory readiness and timely signals.

The role emphasizes governance, analytics, vendor management, and continuous improvement; travel up to 15% may be required.

Qualifications

• Bachelor's degree in a technical field; advanced degree preferred.
• Minimum 8 years of related work experience.
• Minimum 5 years of Quality Assurance experience in the medical device/pharma/regulated industry.
• Previous supervisory/people-management experience.
• Ability to work with remote-office environment.
• Strong leadership and change-management skills.
• Ability to communicate complex results to non-technical audiences.
• Familiarity with GDP, CAPA, and document change control practices.

Responsibilities

• Provide global governance for Post-Market Surveillance data, analytics, and reporting; including regulatory readiness.
• Lead the MedTech Post-Market Surveillance operating model across franchises.
• Translate requirements into policies, procedures, systems, controls, and training plans.
• Oversee methods for identifying product signals and adverse-event trends.
• Support data scientists in developing analytical methods and AI capabilities.
• Ensure governance of data quality, validation, change control, and sustainability.
• Drive continuous improvement and harmonization of processes; automate where possible.
• Partner with stakeholders on surveillance priorities, regulatory needs, and data-analysis needs.
• Support Post-Market Surveillance submissions and health authority responses.
• Monitor vendor performance and drive corrective actions and value creation.
• Identify value-creation opportunities through automation and standardization.
• Coach and develop staff; manage resources and succession.

Skills

Leadership

Stakeholder management

Data analytics

Program management

Change management

Regulatory knowledge

Vendor management

Communication

Education

Bachelor's degree in a technical field

Job description

Johnson & Johnson seeks a Senior Manager, Post-Market Surveillance Governance to lead global PMS processes, systems, and data across MedTech. You will collaborate with franchises, Medical Safety, Regulatory, Clinical, and IT to ensure regulatory readiness and timely signals.

The role emphasizes governance, analytics, vendor management, and continuous improvement; travel up to 15% may be required.