13 ott - Firenze
MIRA
Mira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 300,000 customers. In 2023, we were recognized by Inc. 5000 as America's fastest-growing femtech company.
Mira’s breakthrough innovation was creating the market’s only FDA-compliant at-home hormone monitor with quantitative testing technology. From the beginning, our mission has been to make hormone data accessible and meaningful - so women can understand their bodies and make confident health decisions at every stage of life, from cycle health and family planning to hormonal imbalances and the menopause transition.
We are committed to improving real health outcomes through personalized insights, cutting-edge technology, and science-backed data—turning hormone information into practical guidance for everyday wellbeing.
About the position
We are looking for a Regulatory Submission Specialist to lead and support the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices. The role will ensure that clinical, analytical, usability,
risk-management, quality, and labelling evidence is compiled into clear, submission-ready technical documentation and supports regulatory compliance throughout the product lifecycle.
The ideal candidate has experience in regulatory submissions, technical documentation and clinical-performance evidence, and international IVD regulatory requirements.
Responsibilities
- Prepare, compile, and maintain IVD regulatory submission dossiers and associated technical documentation.
- Review intended-use statements, product claims, instructions for use, labelling, advertising materials, and product specifications for regulatory alignment.
- Assess analytical, clinical-performance, usability, stability, software, and risk-management evidence to confirm it supports the device’s intended purpose and claims.
- Coordinate evidence collection from internal teams, manufacturers, clinical research organisati
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