Chief of Regulatory Affairs & Quality (m/w/d)

About us

Aortex develops patient-specific stent grafts for the endovascular treatment of aortic aneurysms. A significant share of affected patients cannot be treated with today's standard off-the-shelf devices due to their anatomy, and are therefore excluded from gentle, minimally invasive therapy. It is precisely for these patients that we are developing a new generation of devices: an ultra-thin, precision-woven polymer membrane combined with a self-expanding nitinol stent, manufactured using a patented weaving process and geometrically derived from each individual patient's CT imaging.

We are an early-stage startup based in Hamburg, founded by two engineers with backgrounds in industrial series development and strategy consulting. With this position, we are establishing our second site in Magdeburg, which you will help build from day one. Our German patent has been granted, the international application is underway, our first prototypes have been characterized, and we work closely with university medical centers and established contract manufacturers. Ahead of us lies the path to first clinical use and approval of a Class III medical device, including the required preclinical testing and animal studies.

That's where you come in: you will take on regulatory responsibility for our product and build our quality management system from the ground up. Rather than contributing to an existing system, you decide what it looks like.

Your responsibilities

• Develop Aortex's regulatory strategy for Europe and the US, define the conformity assessment route and timeline for our Class III device, and lead the selection of and collaboration with the Notified Body.

• Build our quality management system in accordance with ISO 13485 and take it through to certification.

• Own risk management in accordance with ISO 14971 as well as the planning of the biological evaluation in accordance with ISO 10993.

• Structure the technical documentation, determine the applicable standards (including ISO 25539-1 and ISO 7198), and derive the test plans for development and verification.

• Plan the preclinical testing strategy, from bench testing and biological evaluation through to a GLP-compliant animal study, and ensure that the resulting evidence meets regulatory expectations.

• Prepare the clinical evaluation and our planned first-in-human study under ISO 14155 from a regulatory perspective, and manage interactions with authorities and ethics committees, including FDA Pre-Submissions and applications for Breakthrough programs.

• Qualify our contract manufacturers from a regulatory standpoint, define requirements for process validation and supplier management, and embed them in contracts.

• Build your own team at our new Magdeburg site over the medium term.

Your profile

• Degree in biomedical engineering, engineering, natural sciences, or a comparable qualification.

• Several years of experience in medical device development, ideally in the cardiovascular field and preferably with aortic stent grafts or related implantable Class III devices.

• In-depth knowledge of MDR and FDA regulatory requirements, including the respective approval pathways for high-risk devices.

• Hands-on experience in setting up, maintaining, or auditing an ISO 13485 QMS, as well as in risk management under ISO 14971.

• A preference for rolling up your sleeves rather than delegating, and the ability to set priorities in a small team with limited resources.

• Excellent written and spoken German and English.

• Willingness to travel occasionally to our Hamburg site and to partners.

What we offer

With us, you will have real room to shape things. You will work directly with the founders, decide on the company's regulatory direction, and see your work reflected directly in the product. Our terms and conditions are guided by market and industry standards, and as a company in its build-up phase we also have the flexibility to work with you on a setup that fits your personal circumstances. Your permanent place of work is Magdeburg, where we are building our second site and where you will be among the first people on the team. If you relocate for the role, we will support you with the move. The position is designed as full-time, but we are happy to discuss part-time arrangements.

Above all, you will be working on a product that can give people access to a treatment that is currently out of their reach.

How to apply

Send your CV to henry.stehle@aortex.eu. We don't need a traditional cover letter or a photo. Instead, write us three bullet points on the most exciting regulatory project you have worked on so far and why Aortex interests you. Please also let us know your salary expectations.

We welcome applications regardless of ethnic origin, gender, religion or belief, disability, age, or sexual identity. What matters to us is what you can do and what you want to achieve.