What are the responsibilities and job description for the Medical Device Regulatory Specialist position at Astraveus?
Astraveus is a French startup developing innovative automated bio-manufacturing equipment designed to support the production of cell therapies in a closed system, in compliance with the Good Manufacturing Practices. This cutting-edge technology integrates software and advanced analytics. Our equipment is aimed at international markets, including the USA, Europe, and Asia.
Location : Kremlin Bicêtre
Reports to : VP QARA
As part of our continuous growth, we are looking for a detail-oriented and knowledgeable MD 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.
- Education : Advanced degree in engineering, pharmacy, or related field with strong knowledge of the MDR 2017 / 745 and technical documentation requirements.
- Experience :
- 3 years of experience in regulatory affairs within the pharmaceutical and medical device industry with hands-on experience in preparing, writing and submitting regulatory filings.
- In-depth working knowledge of global regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820), and a strong understanding of the different MD regulatory approval processes is expected.
- Ability to apply knowledge to device development (design, control, process validation) and authoring of design history files / technical files.
- Experience in Software development as per IEC 62304 will be an asset. Diverse background in various classes and families of devices, product codes, as well as materials is a plus.
- Experience in early engagement meetings such as Quality Innovation Group (QIG), INTERACT, or ITF meetings is preferred (EMA and FDA interactions).
- Skills :
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Exceptional attention to detail and organisational skills
- Strong verbal and written communications, fluency in French and English (written and verbal)
- Adaptable with the ability to switch priorities
- Strong problem-solving skills and ability to think strategically and see the big picture
- Process oriented