Introduction:
Astraveus is a French start-up created in 2016 specialized in the development of the Lakhesys Benchtop Cell Factory™ for the production of cell therapies.
Cell and gene therapies are composed of living cells with high therapeutic potential such as genetically modified lymphocytes to attack cancerous cells. Those therapies allow to cure incurable cancers and genetic diseases but they are currently too complex and expensive to produce. This results in substantial selling prices per patient, typically between 0.5 and 2 million euros.
Astraveus aspires to dramatically increase accessibility to genetically modified cell therapies by enabling more efficient process development and manufacturing at order-of-magnitude lower cost. To achieve this goal, we are developing innovative solutions that exploit the performance and precision of microfluidic modules in a fully automated environment.
Position Overview:
Location: Kremlin Bicêtre
Reports to: VP QARA
As part of our continuous growth, we are looking for a detail-oriented and knowledgeable Medical Device Regulatory Specialist to join our quality and regulatory affairs team. In this role, you will be at the forefront of regulatory strategy, working closely with the VP QARA, and building comprehensive Design History Files (DHF) and Device Master Files (DMF) for our cutting-edge products. With a strong focus on collaboration with cross-functional teams and precision, you will help shape the future of our innovative devices, such as Lakhesys and its software, and contribute to advancing regulatory frameworks for next-generation technologies. You will play a key role in navigating the complexities of regulatory requirements to facilitate interaction with agencies and ultimately ensure the compliance and commercialisation of Lakhesys.
Main responsibilities:
- You will support the VP QARA in staying ahead of legislative changes and ensuring compliance of our products in development. This will be related to activities such as regulatory intelligence, monitoring changes in pharmaceutical legislation, specifically in medical device legislation and platform technology legislation.
- With the VP QARA, you will develop communications to competent authorities (Health agencies, Notified Bodies) and attend interaction meetings with regulatory bodies.
- You will work closely with the VP QARA in forming industry working parties with other stakeholders to be able to contribute to the refinement of the regulatory framework for innovative device like Lakhesys, including software and single-use consumable.
- You will be the go-to person with the Head of QA for developing and keeping our technical and regulatory files up to date, supporting filing of Device Master Files, and ensuring our products meet global legislation.
