Position is responsible for evaluating complaint investigation data to understand product performance and patient impact, draw conclusions related to event safety and potential actions required, determine whether safety reports are required to be sent to global government authorities, create and file safety reports (MDR/Vigilance); document event conclusions related to complaint events, and ensuring completeness and accuracy of complaint records.
All positions are responsible for following applicable AMS policies and procedures as defined by their manager.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Evaluate incoming event information from numerous internal and external sources (i.e. source documents) and independently determine whether it is a complaint according to FDA or ISO 13485 definitions.
Review complaint files, including all information related to the product, the medical procedure, patient condition, and relevant risks to determine if they meet MDR/Vigilance reporting criteria per regulations in each country in which AMS markets the product.
Prepare and submit both the initial and follow up MDR and Vigilance Reports as needed, ensuring that all regulatory requirements are followed.
Interact with global regulatory agencies on AMS’ behalf to respond to questions on filed MDRs/vigilance reports, requests for information, or to respond to questions on complaints and MDRs during inspections by regulatory authorities.
Directing the Complaint Investigators to gather details needed to complete complaint evaluation. This includes providing guidance on whether manufacturing, product design, CAPA, or clinical follow-up is needed.
Assist/perform investigations when necessary.
Ensure completeness and accuracy of complaint files.
Review complaint files for closure. Clearly document investigation conclusions and justifications as part of the record. Responsible for ensuring that all regulatory and internal requirements have been met.
Provide training and education of the complaint process and MDR/Vigilance reporting requirements to AMS employees as needed.
Perform trend analysis of complaint data and participate in corrective action process. Understand when a complaint or complaint trend may indicate need for corrective action and work with design, manufacturing and quality engineering teams to further evaluate.
Participate in Post Market Surveillance process as a key provider of field experience using AMS products.
Produce clear, compelling and accurate reports/files.
Support requests for complaint information from customers (internal and external).
Thoroughly understand AMS products, including design characteristics, clinical application, labeling content, intended use, and associated risks.
Maintain a working knowledge of current and emerging safety reporting regulations (MDR/Vigilance) in primary countries AMS markets in.
- Education which meets the Qualified Medical Personnel definition in 21 CFR 803 (licensed, registered, or certified to administer healthcare or has a diploma or 4 year degree in scientific discipline such as: Biomedical Engineering, Nursing or Pre-Med).
- Medical knowledge and understanding (expertise) required
- Strong understanding of 21CFR820, 21CFR803, ISO 13485 and related MEDDEV guidances required
- Proven ability to interpret regulations, preferably in a global setting
- Medical device complaint handling experience preferred
- MDR/Vigilance reporting experience desired
- Successful history of evaluating quality complaints
- Analytical approach to problem solving. Uses critical thinking methodologies
- Uses rigorous logic and methods to solve difficult problems with effective solutions
- Proven track record of making complex decisions based on analysis, wisdom, experience and judgment
- Decision Quality. Makes good, timely decisions based upon a mixture of analysis, wisdom, experience, and judgment.
- Able to write clearly and succinctly in a variety of communication settings and styles.
- Able to verbally communicate in a way that clearly conveys the intended message
- Conduct objective, honest analysis
- Able to review data and quickly identify gaps in data, trends, or inconsistencies when present.
- Able to work well in a matrixed organization
- Strong attention to detail
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
- Able to lift and carry up to twenty pounds with reasonable accommodations
- Able to sit/stand for extended periods of time with reasonable accommodations
American Medical Systems - 17 months ago
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