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Remote Regulatory Affairs Specialist II

Tampa, FL 33607

Posted: 06/12/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 608556 Is job remote?: Yes Country: United States

Job Description

Job Description:

Must Haves:

Need to have good experience assessing the impact from changes to devices - US and EU and CAN.
510K Experience
Must be extremely organized, have to be good at time management and multitasking.

- Perform regulatory assessments for US, EU, and Canada for changes on commercialized medical device product
- Work with global regulatory affiliates to compile global regulatory impact for changes on commercialized medical device products
- Create submissions for US FDA and Health Canada as well as compile and maintain STeDs for changes on commercialized medical device products
- Coordinate and clearly communicate with team members to properly implement changes to medical devices
- Remediate product labeling and STeDs for EU MDR compliance
- Various other duties within the medical device regulatory lifecycle maintenance space
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