In this role, you will be responsible for
support the full product lifecycle by assessing changes made to the device post launch to determine if the changes will impact the current clearance of the device.
In this role, you will usually work with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.
In this role, the selected candidate will advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
In this role, the selected candidate will act as core member on project teams to provide regulatory guidance and strategic regulatory planning in support of new product development and existing product support.