To support its fast-growing strategy, Alcediag is looking for an experimented Head of Quality assurance and Regulatory affairs. As the leader of Quality assurance and Regulatory affairs you will report directly to C-level management and interact with project leaders.
- Lead the Quality System Management (ISO 13485, IEC 62304)
- Construct a strategy, drive a plan, and take actions to achieve a high level of quality
- Structure the quality control process and team
- Lead the Regulatory affairs process (Directive 98/79/CE, 2017/746/CE, FDA)
- Conduct discussions with notified bodies and national authorities
- Propose a strategy to comply with specific regulatory requirements
- A 5 to 10 years’ experience in IVD industry
- Fluent in English and French
- A university degree related to medical activities with a strong quality and regulatory constraint
- Analytical skills
- Motivation and commitment to results
- Demonstrated ability to learn key products and processes quickly
Who are we?
ALCEDIAG is a company developing epigenetics diagnostic tests and biomarkers in mental health. ALCEDIAG technology is based on the measurement of RNA editing based biomarkers measured in blood using NGS and artificial intelligence.
The first test to characterize bipolar depressed patients EDIT-B has been CE marked in 2022. A clinical trial to validate the IVDR version of the test is ongoing. The company has proprietary product generated after a R&D process.