Regulatory Affairs Specialist

Regulatory Affairs Specialist
In your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams you will ensure submissions are accurately prepared and comply with global regulations. The position is on-site and may require additional hours and/or travel as necessary to complete time-sensitive projects.
Duties and Responsibilities:

+ Prepare, review, and submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other relevant regulatory bodies and/or Distributors.

+ Develop regulatory strategies for new product submissions, modifications, and renewals to ensure compliance with local and international regula...

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