Regulatory Submission Specialist (EU IVDR / CE-mark))

Mira; Fatih; Remote; TRY 4,936,000 - 6,910,000; Full time

Benefits offered by this job

Remote-friendly

Competitive salary

Career growth

Flexible hours

Bonus program tied to OKRs

Job summary

Mira is seeking a Regulatory Submission Specialist to lead and support the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices. The role ensures evidence across analytical, clinical-performance, and usability remains compliant through the product lifecycle.

This remote role offers collaboration with global teams and a focus on women’s health diagnostics. The ideal candidate has 2+ years in regulatory affairs for medical devices or IVDs, experience with

Qualifications

• Bachelor degree in Regulatory Affairs, Biomedical Science, Medical Laboratory Science, Biotechnology, Engineering, Life Sciences, or related discipline.
• 2+ years of regulatory affairs experience for medical devices or IVDs, including regulatory submissions.
• Experience supporting CE-marking under EU IVDR and knowledge of ISO 13485, ISO 14971, ISO 20916.
• Familiarity with IVD regulatory frameworks, post-market surveillance, and vigilance requirements.
• Strong technical writing, document control, and project management skills.

Responsibilities

• Prepare and maintain IVD regulatory submission dossiers and technical documentation.
• Review labels, use statements, product claims and specifications for regulatory alignment.
• Assess analytical, clinical-performance, usability and risk-management evidence for regulatory support.
• Coordinate evidence collection with internal teams, CROs, labs, and consultants.
• Develop regulatory evidence plans and gap analyses.
• Prepare responses to regulatory authority questions and audit-related documentation.
• Maintain regulatory intelligence on applicable IVD regulations and standards.
• Support post-market regulatory activities and lifecycle changes.
• Collaborate with Quality, R&D, Clinical, Product and Commercial teams to stay compliant.

Skills

Regulatory submissions

Technical writing

Stakeholder coordination

Quality systems

IVD knowledge

Education

Bachelor degree in Regulatory Affairs or related

Job description

About 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.

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

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 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.

Requirements

• 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 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.

Details

The role is a remote position, with a 40-hour workweek, flexible working hours, and occasional overlap with the US team.

What We Offer

• Join 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 care
• Be part of a passionate, highly motivated, and international team dedicated to making a real difference in people’s lives
• Thrive in a fast-paced startup environment where your work directly impacts company growth, strategy, and key decisions
• Enjoy real opportunities for career growth, with the ability to shape, build, and develop teams as we scale
• Work in a flexible, fully remote environment that supports autonomy, ownership, and independence
• Receive a competitive salary along with a performance-based bonus system tied to OKRs