Regulatory Operations Leader

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’