Principal Regulatory Affairs Specialist - REMOTE

Captionhealth in Remote

$110,500 - $123,500

About Caption Health

Caption Health’s mission is to detect disease early – when there is the highest potential for impact – by leveraging artificial intelligence and ultrasound. Our breakthrough AI platform enables any healthcare professional to perform high-quality ultrasound exams for early disease detection, in convenient and lower-cost outpatient settings including patients’ homes. It was recognized as one of TIME’s 100 Best Inventions of 2021 and one of Fast Company’s Next Big Things in Health Tech.

Through our work with health plans, providers, patients, and industry partners, we are transforming care, expanding access, and reducing costs.

To learn more, visit captionhealth.com .

We are seeking an experienced RAQA professional to make an impact on our RAQA team! The Principal Regulatory Affairs Specialist is responsible for providing strategic and tactical support of Caption Health’s software-as-a-medical device (SaMD) products. The individual serves as regulatory lead for US FDA, EU and ROW regulatory submissions, reporting directly into the Head of Regulatory Affairs and Quality Assurance.

Salary range: $110,500-$123,500

Your base pay will depend upon many factors, including your skills, qualifications, experience, and location. All ranges are subject to change.
Caption Health is an Equal Employment Opportunity employer that proudly pursues and hires a diverse workforce. Caption Health does not make hiring or employment decisions on the basis of race, color, religion or religious belief, ethnic or national origin, nationality, sex, gender, gender-identity, sexual orientation, disability, age, military or veteran status, or any other basis protected by applicable local, state, or federal laws or prohibited by Company policy. Caption Health strives for a healthy and safe workplace and strictly prohibits harassment of any kind. Pursuant to the San Francisco Fair Chance Ordinance and other similar state laws and local ordinances, and its internal policy.
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