Head of Regulatory Affairs

San Francisco /
Operations/Sales/Biz Dev /
Sirona’s mission is to make the highest quality healthcare available to everyone. We’re building a diagnostic engine that learns from and empowers the world’s most accurate radiologists–but enabling diagnosticians is just the beginning. Through our end-to-end workflow, we’re working to improve the quality and efficiency of the entire episode of care, simplifying the process of medicine and allowing doctors to focus on patients. We are interdisciplinary thinkers who are passionate about technology and medicine, and believe in the power of technology to protect and preserve human life. We’re in stealth mode and we’re hiring.

The Head of Regulatory Affairs at Sirona is responsible for refining and executing the regulatory strategy for our product, primarily in the domestic market. This includes development, testing, marketing claims, and distribution of the product.  The Head of Regulatory Affairs will work with the rest of the Sirona team to bring the next generation of medical imaging software to the market.

Responsibilities

    • Development of regulatory strategy for new product pipeline, esp. AI functionality
    • Preparation and execution of regulatory actions including registration, pre-sub, 510(k), PMA, CE mark
    • Participate in planning and communication of clinical trials process to support regulatory submission
    • QMS and quality process
    • Post-marketing surveillance (NC/CAPA, MDR)
    • Managing quality audits
    • Expanding regulatory team
    • Work with product and customer success teams to maintain culture of quality and excellence
    • Patient privacy compliance including HIPAA and SOC 2

Requirements

    • 5-8 years industry experience in medical device regulation
    • At least 3-4 years experience with SaMD highly preferred
    • Experience writing regulatory submissions
    • Prior experience in startup environment a plus
    • Excellent organizational and communications skills
    • Strong motivation to meaningfully advance healthcare technology while protecting patient safety

Benefits

    • Stock
    • Competitive salaries
    • Unlimited PTO
    • Medical, dental
    • Vision insurance
    • Life Insurance
    • 401(k) Apple equipment
    • Sponsorship for conferences