Descripción de la oferta
About MiraMira 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 PositionWe 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 .ResponsibilitiesPrepare, 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.RequirementsBachelor 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 documentation and performance evaluation requirements.Working knowledge of IVD quality and regulatory frameworks, including ISO 13485, ISO 14971, ISO 20916, and applicable post-market surveillance and vigilance requirements.Experience reviewing or preparing analytical-performance and clinical-performance documentation for IVDs, including sensitivity, specificity, precision, reproducibility, interference, stability, and method-comparison studies.Familiarity with relevant IVD standards and guidance, including CLSI EP guidelines; experience with self-tests or consumer-use IVDs is highly desirable.Excellent technical writing, document-control, project-management, and stakeholder-coordination skills, with the ability to work independently in a fast-paced startup environment.DetailsThe role is a remote position, with a 40-hour workweek, flexible working hours, and occasional overlap with the US team.What We OfferJoin one of the fastest-growing femtech companies in the U.S., driven by a strong mission to advance women's health and expand access to careBe part of a passionate, highly motivated, and international team dedicated to making a real difference in people's livesThrive in a fast-paced startup environment where your work directly impacts company growth, strategy, and key decisionsEnjoy real opportunities for career growth, with the ability to shape, build, and develop teams as we scaleWork in a flexible, fully remote environment that supports autonomy, ownership, and independenceReceive a competitive salary along with a performance-based bonus system tied to OKRsRecruiting processStep 1 'Screening call with HR' - Step 2 'Assessment task' - Step 3 'Interview with Director of Regulatory and Quality' - Step 4 'Cultural Interview'#J-18808-Ljbffr
