Senior Post-Market Vigilance Specialist

Cardinal Health; Indianapolis (IN); On-site; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

HSA

401k

Job summary

Cardinal Health is seeking a Post Market Vigilance Senior Specialist to join the Post Market Surveillance team. You will ensure regulatory compliance and maintain safety across the medical device portfolio, handling complaints, investigations, and regulatory reporting.

The role requires 2–4 years in post market surveillance or related quality discipline, with strong analytical and collaborative skills in a regulated environment. Competitive benefits and an inclusive workplace are provided.

Qualifications

• Bachelor’s degree 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

Bachelor's degree

Experience 2–4 yrs

Analytical skills

Team collaboration

Education

Bachelor’s degree in a related field

Tools

SmartSolve

Agile PLM

Adobe EchoSign

Job description

Cardinal Health is seeking a Post Market Vigilance Senior Specialist to join the Post Market Surveillance team. You will ensure regulatory compliance and maintain safety across the medical device portfolio, handling complaints, investigations, and regulatory reporting.

The role requires 2–4 years in post market surveillance or related quality discipline, with strong analytical and collaborative skills in a regulated environment. Competitive benefits and an inclusive workplace are provided.