Senior Post‑Market Vigilance Specialist

Cardinal Health; Denver (CO); Remote; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

HSA

401k

MyFlexPay

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health is seeking a Post Market Vigilance Senior Specialist to join our Post Market Surveillance team. You will oversee the CAH post market surveillance processes to ensure regulatory compliance and quality across the medical device portfolio.

You will review complaints, coordinate investigations, and perform regulatory assessments while collaborating with Quality, Engineering, and Operations to improve processes and maintain high safety standards.

Qualifications

• Bachelor’s degree in a related field or equivalent work experience preferred.
• 2–4 years of relevant experience in post market surveillance, complaint handling, or a related medical device quality discipline preferred.
• Strong organizational, analytical, and problem-solving skills.
• Ability to work both independently and collaboratively in a fast-paced, regulated environment.

Responsibilities

• Review, evaluate, and process medical device complaints in full compliance with applicable regulations and internal procedures.
• Manage translations through approved translation tool.
• Coordinate and conduct follow-ups with internal and external stakeholders to obtain additional information and facilitate device returns.
• Complaint coding using established proceduralized malfunction codes.
• Perform regulatory assessments and decision tree analyses.
• Review and approve complaint investigations, ensuring thorough documentation and timely closure.
• Conduct investigations for no-sample complaints and support NC and CAPA reviews as applicable.
• Support other tasks as needed such as complaint data pulls and regulatory reporting
• Knowledge of business platforms and processes SmartSolve, Agile PLM, Adobe EchoSign.
• Collaborate effectively with cross-functional partners in Quality, Engineering, and Operations to resolve issues and drive continuous improvement.
• Maintain strong attention to detail and ensure accuracy, consistency, and timeliness in all complaint documentation.
• Clear written and verbal communication skills to drive clear alignment of company and department goals

Skills

Organizational skills

Analytical skills

Problem-solving

Education

Bachelor’s degree

Tools

SmartSolve

Agile PLM

Adobe EchoSign

Job description

Cardinal Health is seeking a Post Market Vigilance Senior Specialist to join our Post Market Surveillance team. You will oversee the CAH post market surveillance processes to ensure regulatory compliance and quality across the medical device portfolio.

You will review complaints, coordinate investigations, and perform regulatory assessments while collaborating with Quality, Engineering, and Operations to improve processes and maintain high safety standards.