Posted 5 days ago
Description
About the position
We are looking for a Regulatory Operations Leader to prepare, submit and manage 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 hands-on 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
Recruiting process
Step 1 ‘Screening call with HR’ - Step 2 ‘Interview with Director of Regulatory and Quality’ - Step 3 ‘ Team Fit Interview’ - Step 4 ‘Reference Check’
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