Regulatory Submission Specialist; EU IVDR​/CE-mark

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 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.

We are looking for an 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
.

If you want to challenge yourself at a high-growth startup and make a difference for women’s health, please join us!

• 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 organisations, laboratories, quality teams, and external regulatory consultants.
• Identify evidence gaps and develop regulatory evidence plans, including requirements for analytical studies, clinical performance studies, and lay-user/self-test studies.
• Support the preparation and review of clinical-performance documentation, including study protocols, performance evaluation reports, statistical summaries, and reference-method justifications.
• Prepare responses to regulatory authority questions, requests for information, and audit-related documentation.
• Maintain regulatory intelligence on applicable IVD regulations, standards, guidance, and market requirements.
• Support post-market regulatory activities, including change assessments, vigilance/adverse-event reporting, recalls, corrective actions, and periodic documentation updates.
• Partner with Quality, R&D, Clinical, Product, and Commercial teams to ensure products remain compliant throughout their lifecycle.

• Bachelor degree in Regulatory Affairs, Biomedical Science, Medical Laboratory Science, Biotechnology, Engineering, Life Sciences, or a related discipline.
• 2+ years of experience in regulatory affairs for medical devices or in vitro diagnostic devices, including preparation of technical documentation or regulatory submissions.
• Experience supporting or preparing CE-marking documentation under the EU IVDR (Regulation (EU) 2017/746), including technical…