Senior Post-Market Surveillance Specialist

Cardinal Health; Columbia (SC); On-site; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

MyFlexPay access to wages

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health seeks a Senior Specialist in Post Market Vigilance to lead activities ensuring regulatory compliance and high quality across the medical device portfolio. You will review complaints, coordinate investigations, and collaborate with Quality, Engineering, and Operations to drive improvements.

This role requires 2–4 years in post market surveillance, strong analytical skills, and the ability to work independently in a fast-paced, regulated environment.

Qualifications

• Experience in post market surveillance and complaint handling in medical devices.
• Ability to work independently and in cross-functional teams.
• Strong organizational, analytical and problem-solving skills.
• Knowledge of regulatory requirements and quality systems.

Responsibilities

• Review, evaluate, and process medical device complaints in full compliance with regulations and procedures.
• Coordinate and conduct follow-ups with internal and external stakeholders to obtain more information and facilitate device returns.
• Complaint coding using established malfunction codes.
• Perform regulatory assessments and decision tree analyses.
• Review and approve complaint investigations with thorough documentation.
• Conduct investigations for no-sample complaints and support NC and CAPA reviews.
• Support other tasks such as complaint data pulls and regulatory reporting.
• Collaborate with Quality, Engineering, and Operations to resolve issues and drive improvements.
• Maintain accuracy, consistency, and timeliness in complaint documentation.

Skills

PMV experience

Complaint handling

Regulatory compliance

Organizational

Analytical

Problem-solving

Teamwork

Education

Bachelor’s degree or equivalent

Job description

Cardinal Health seeks a Senior Specialist in Post Market Vigilance to lead activities ensuring regulatory compliance and high quality across the medical device portfolio. You will review complaints, coordinate investigations, and collaborate with Quality, Engineering, and Operations to drive improvements.

This role requires 2–4 years in post market surveillance, strong analytical skills, and the ability to work independently in a fast-paced, regulated environment.