Title : Regulatory Affairs Specialist
Reports to : VP of Quality & Regulatory Affairs
Location: Remote initially then transitions to on-site (Irvine, CA office)
Salary Range: $110,000 - $120,000 per year
Local candidates only; no relocation will be provided for this position.
The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided by a clinical stage startup. You will join a small team who left great jobs to go “all in” with Kardion to bring a great product that they passionately believe in to market. Communication skills, humility, competitive spirit and team fit are paramount.
The Regulatory Affairs Specialist is a key partner within Regulatory Affairs and will have responsibility of the direct execution of some corporate regulatory filings. This role will work independently on some submissions and partner with others in the Regulatory Team on other US FDA filings, including IDEs, 510(k)s and PMA. This position requires someone with both a strong execution mindset and ability to explain regulatory processes to the organization.
Position will initially be remote then transition to on-site when the Irvine, CA office location is available, mid-2025.
Essential Responsibilities
Skills, Qualifications & Key Knowledge Areas
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