Regulatory Affairs and Quality Assurance Manager

Company overview

SkillCell develops biology-based technologies to support objective decision-making.

SkillCell has developed a breakthrough technology of programmable non-living biomachine devices that allow to provide miniaturized, fast and easy tests, with various applications for health, food and environment issues (winner of the French National Center for Scientific Research innovation medal 2020). This new generation patented technology provides critical and decisive information but remains so easy to use that it can be put in anyone’s hands.

SkillCell develops and provides IDIR the first CE-marked urine test for insulin-resistance (IR) identification. IDIR meets high quality standards and requires a light laboratory infrastructure. IR being strongly correlated to overweight and obesity, IDIR allows to alert person on their critical impending health impacts and specially T2 Diabetes.

The company develops disruptive technologies and products with a huge impact on human health. The versatility of our solutions leads us to aims for a global footprint (including developing countries). At SkillCell we have an international team willing to improve the life of every living species on hearth.

The position is located at Montpellier (FRANCE).

Job Summary

The Regulatory and Quality Assurance Manager will be responsible for ensuring that our products and services meet all regulatory requirements, and maintaining our quality management system in compliance with ISO 13485. This role involves developing, implementing, and managing regulatory strategies and quality assurance processes to support our product development and commercialization activities.

Our first challenge will be the ISO 13485 certification of the company. More broadly, as our solution are global, a FDA/CE/developing country regulatory strategy will be developed to optimize our R&D and manufacturing process.


Regulatory Compliance

  • Develop and execute regulatory strategies to ensure compliance with local and international regulations (FDA, IVDR CE, etc.).
  • Prepare technical files in collaboration with different services
  • Submit regulatory filings and documentation, including technical files and product registrations.
  • Monitor and interpret regulatory changes and advise the company on necessary actions to maintain compliance.
  • Manage the EUDAMED account of the company

Quality Assurance

  • Oversee the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 standards.
  • Develop, review, and update quality policies, procedures, and SOPs.
  • Conduct internal audits and manage external audits and inspections.
  • Ensure effective CAPA (Corrective and Preventive Actions) and Change Controls processes are initiated and implemented.
  • Lead risk management activities, including risk assessments and mitigation plans.

Product Development Support

  • Support R&D and manufacturing to ensure that quality and regulatory requirements are integrated into the product development process.
  • Review design control documentation, including design outputs, and verification/validation plans.

Training and Education

  • Provide training and support to employees on regulatory and quality requirements.
  • Foster a culture of quality and continuous improvement within the organization.


  • Master’s degree in Life Sciences
  • Minimum of 3 years of experience in regulatory affairs and quality assurance in the medical device or biotechnology industry, with a focus on in vitro diagnostics.
  • In-depth knowledge of ISO 13485, FDA regulations, and other relevant international standards.
  • Proven track record of successfully managing regulatory submissions and quality management systems.
  • Strong analytical, problem-solving, and project management skills.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a cross-functional team.
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