Director of Regulatory Affairs
We are seeking a Director of Regulatory Affairs to join our executive team. This is a key role where you will define and lead the company's global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly.
* • Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities.
* • Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial timelines.
* • Serve as the primary liaison with regulatory authorities representing the company in all regulatory interactions negotiations.
* • Build lead a high-performing team to support early-stage product development later-stage market access activities.
* • Monitor interpret evolving requirements to ensure proactive compliance across multiple geographies integrating into project plans strategic decision-making.