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The Regulatory Affairs Specialist will provide worldwide regulatory affairs support for medical devices delivering Tumor Treating Fields (TTFields), a novel cancer treatment. The Regulatory Affairs Specialist is responsible for activities that lead to and maintain regulatory approval for these medical devices. This position will provide an opportunity to work independently, as well as with other functions within the company.

Responsibilities:
- Provide regulatory support for the preparation of regulatory submissions globally for both existing and new products.
- Provide clinical input to support regulatory submissions, working closely with the medical personnel within the company on preparing clinically-oriented responses.
- Work with clinical development, engineering, quality, manufacturing, supply chain, safety and other internal teams as needed in order to collect relevant data supporting submissions.
- Respond to questions from different regulatory authorities
- Communicate directly/indirectly with regulatory authorities and participate in meetings with regulatory authorities as required.
- Meticulously maintain regulatory files in the companys electronic database.