Sr Specialist, Post Market Vigilance
About this role
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 programs
Application window anticipated to close: 9/28/2026 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
To read and review this privacy notice click here
Originally posted on Himalayas