Sr Specialist, Post Market Vigilance

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

## Sr Specialist, Post Market VigilanceApply: US-Nationwide-FIELD: Full time: Posted Today: 20187536***What Post Market Vigilance contributes to Cardinal Health***Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.Post Market Vigilance assesses clinical customer experiences for the company's products and services and maintains regulatory compliance with regard to product complaints and the reporting of safety adverse events for all products manufactured or distributed by the company.**Post Market Vigilance Sr Specialist**Cardinal Health (CAH) is currently seeking a Post Market Vigilance Senior Specialist to join our Post Market Surveillance team. In this role, you will engage in all activities related to the CAH post market surveillance processes by ensuring regulatory compliance and maintaining the highest standards of quality and safety across CAH’s medical device portfolio.***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***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.***What is expected of you and others at this level**** Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks* Works on projects of moderate scope and complexity* Identifies possible solutions to a variety of technical problems and takes action to resolve* Apply judgment within defined parameters* Receives general guidance and may receive more detailed instruction on new projects* Work reviewed for sound reasoning and accuracy**Anticipated salary range**: $76,700 - $98,550**Bonus eligible**: No**Benefits**: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.* Medical, dental and vision coverage* Paid time off plan* Health savings account (HSA)* 401k savings plan* Access to wages before pay day with myFlexPay* Flexible spending accounts (FSAs)* Short- and long-term disability coverage* Work-Life resources* Paid parental leave* Healthy lifestyle programsApplication window anticipated to close: 9/28/2026 \\*if interested in opportunity, please submit application as soon as possible.