Regulatory Affairs Specialist II

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 communicate with team members to properly implement changes to medical devices

- Remediate product labelling and STeDs for EU MDR compliance

- Various other duties within the medical device regulatory lifecycle maintenance space