Cardinal Health Sr. Specialist, Customer Advocacy Clinical in Mansfield, Massachusetts
What Customer Advocacy - Clinical contributes to Cardinal Health
Customer Advocacy - Clinical is responsible for managing the clinical related customer experiences for our products and services and maintaining regulatory compliance with regards to product complaints for all products manufactured or distributed by Cardinal Health.
- Demonstrates product knowledge supported by clinical experience using the products or competitive products.
- Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
- Follows written regulatory procedures to determine the significance of each received complaint and accurately documents customer feedback.
- Interacts and successfully works with the customer to define and resolve issues.
- Bachelor’s in related field, or equivalent work experience, preferred
- 2+ years’ experience in related field, preferred
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 actions to resolve
- Applies judgment within defined parameters
- Receives general guidance may receive more detailed instruction on new projects
- Work reviewed for sound reasoning and accuracy
Essential Duties and Responsibilities:
- Works independently on and resolves complex issues
- Has conceptual understanding of all Quality functions
- Prioritizes work to meet deadlines
- Investigates and processes product complaints while maintaining compliance to all regulations
- Investigation and documentation of field clinical events and follow-up with Sales Reps/OUS QRA
- Accountable for compliance with all Food & Drug Administration (FDA), European Union Medical Device Directives (MDD) and other regulations governing adverse event reports such as Medical Device Reports (MDR), Medical Device Vigilance (MDV) and other reports.
- Evaluates Product complaints for MDR/MDV/Other regulatory agencies as applicable
- Devises new approaches to problems encountered
- Work requires a broad knowledge of products and clinical applications of such products
- Assist with review of analysis reports and preparation of customer responses
- Independently performs assignments with instructions as to the general results expected
- Performs work, which involves conventional complaint handling processes but may include a variety of complex investigations and follow-ups
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
- Practices company safety, quality policies and procedures, actively requires conformance
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets.
- Performs other duties assigned as needed
Education, Training and Experience:
- Bachelor of Science or equivalent
- 3+ years of related experience and/or training preferred.
- Equivalent combination of education and experience
- Experience in the medical device industry preferred
- Knowledge of Medical Device Complaint Handling and Reporting Regulations
- Department Management could evaluate and substitute any of the educational requirements by demonstrated experience in the field.
Required Knowledge, Skills, Abilities and Certifications/ Licenses:
- Healthcare Certification and/or license in specific discipline would be an asset
- Knowledge of product use in a clinical setting is an asset
- Excellent written and oral English communication skills
- Proficient investigative and analytical skills
- Computer literate of MS Word, MS PowerPoint, MS Excel.
- Knowledge Smartsolve a plus.
- Ability to interact with individual/groups at all levels, good presentation/training skills
- Ability to identify priorities and function independently a must
Due to COVID-19, this position will be fully remote to start.
Normal state will require the employee to be physically in the office, however flexible schedules are considered.
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 (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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