Sr Specialist, Post Market Vigilance

Cardinal Health; United States; On-site; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical benefits

401k plan

Paid time off

Health Savings Account (HSA)

FSAs

Disability coverage

Work-life resources

Parental leave

Job summary

Cardinal Health is seeking a Post Market Vigilance Senior Specialist to join our Post Market Surveillance team in the United States. You will ensure regulatory compliance and uphold quality and safety across Cardinal Health’s medical device portfolio.

The role involves reviewing complaints, coordinating investigations, and performing regulatory assessments. Strong communication and cross-functional collaboration are essential to drive continuous improvement and timely closure of investigations.

Qualifications

• Bachelor's degree or equivalent work experience preferred.
• 2–4 years of relevant experience in post market surveillance or complaint handling in medical devices preferred.
• 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 compliance with regulations.
• Coordinate follow-ups with stakeholders to obtain information and facilitate device returns.
• Perform regulatory assessments and decision tree analyses.
• Review and approve investigations with thorough documentation and timely closure.
• Support complaint data pulls and regulatory reporting.

Skills

Analytical skills

Organizational skills

Problem-solving

Education

Bachelor's degree in a related field

Tools

SmartSolve

Agile PLM

Adobe EchoSign

Job description

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.
• 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

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

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.