Senior Post-Market Vigilance Specialist

Cardinal Health; Northern (KY); Hybrid; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical, dental, vision

Paid time off

Health Savings Account (HSA)

401k plans

MyFlexPay

Job summary

Cardinal Health is seeking a Post Market Vigilance Senior Specialist to support the post market surveillance program across the medical device portfolio. You will ensure regulatory compliance and high-quality investigation documentation while coordinating with cross-functional partners.

The role requires a bachelor’s degree with 2–4 years of related experience, strong analytical and communication skills, and the ability to work independently in a fast-paced, regulated environment.

Qualifications

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

Responsibilities

• Review, evaluate, and process medical device complaints in full regulatory compliance.
• Coordinate translations and follow-ups with internal and external stakeholders.
• Code complaints using established malfunction codes and perform regulatory assessments.
• Review investigations and ensure timely closure; support CAPA reviews.
• Investigate no-sample complaints and assist with data pulls and regulatory reporting.
• Collaborate with Quality, Engineering, and Operations to drive improvements.

Skills

Post market surveillance

Regulatory compliance

Complaint handling

Analytical skills

Cross-functional collaboration

Education

Bachelor’s degree or equivalent

Tools

SmartSolve

Agile PLM

Adobe EchoSign

Job description

Cardinal Health is seeking a Post Market Vigilance Senior Specialist to support the post market surveillance program across the medical device portfolio. You will ensure regulatory compliance and high-quality investigation documentation while coordinating with cross-functional partners.

The role requires a bachelor’s degree with 2–4 years of related experience, strong analytical and communication skills, and the ability to work independently in a fast-paced, regulated environment.