Regulatory Compliance Expert

6 days ago


Uppsala, Uppsala, Sweden Rarity Bioscience Full time

Rarity Bioscience Overview

We are a dynamic and innovative company with a strong focus on research and development.

Our products are based on superRCA technology, which offers ultra-high sensitivity detection of multiple mutation targets simultaneously in liquid biopsies.

Job Description

As a Verification Specialist, you will be responsible for leading verification studies and analytical performance evaluations for our research-use and diagnostic products.

This includes designing and refining protocols, ensuring accurate documentation, and collaborating cross-functionally within the company to translate research into scalable, market-ready products.

Main Tasks

  • Designing and leading verification and validation studies, including analytical performance evaluations, for research-use and diagnostic products.
  • Defining performance requirements, refining existing protocols, and defining new ones when needed, as well as ensuring that the documentation is accurate and fit for purpose.
  • Preparing documentation to support in vitro diagnostic device (IVD) registration in compliance with applicable regulations and guidelines.
  • Assisting in areas such as requirement management, change management, and risk management.
  • In collaboration with statistical expertise and R&D colleagues, evaluating performance studies and reports.

Required Skills and Qualifications

  • A university degree in Molecular/Cell Biology, Biotechnology, Biochemistry, or a related field.
  • 3-5 years of experience in product development, particularly in verification and validation within a regulated environment.
  • Proficiency in report writing and familiarity with statistical methods and data analysis.
  • Experience collaborating with statistical experts and designing performance studies according to standards and guidelines.
  • Professional fluency in English, both written and verbal.

Experience from flow cytometry and molecular biology techniques, including PCR and other DNA amplification methods is a plus.



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