Regulatory Affairs Specialist
Let’s transform healthcare
At Vitestro, we will be the first to introduce autonomous blood drawing technology to European hospitals. Our team is growing rapidly. Do you have the pioneering mindset required to introduce this breakthrough innovation to patients? This is your opportunity to join us as
REGULATORY AFFAIRS SPECIALIST
Who we are
Staffing shortages in healthcare, aging population and rise in chronic diseases are huge problems that the health sector is currently facing. At Vitestro, it's our mission to improve patient care with our unique technology. And we're bloody serious about that!
By combining 3D ultrasound based on AI and precision robotics, our team created an autonomous blood drawing device. We are the first company in the world to introduce this innovation, that will revolutionize the healthcare industry.
Improving the lives of millions of patients runs through the veins of our business. Our extraordinary team of over 50 people loves to work on the toughest challenges to find cutting-edge solutions.
We realize breakthroughs and change the future of health care. What's not to love about that? Our can-do mentality and passion to work on the toughest challenges to find cutting-edge solutions leads us to a huge success: the product launch at the end of 2024. And for that, we need your help.
REGULATORY AFFAIRS SPECIALIST at Vitestro
Reporting to Jasmine Beukema, Head of RA & QA, and as part of the regulatory team, you will share responsibility for all the Regulatory Affairs within the company. Several regulatory consultants are involved, each with their own expertise to help us crack the most difficult regulatory challenge. There are no comparable devices on the market yet; Vitestro will be the first company in the world to receive CE approval on the device. Your timing is perfect: you will be joining Vitestro during probably the most interesting and challenging period, as the next 12 months will be incredibly important. Additionally, Vitestro is preparing an FDA submission. The system consists of a variety of subsystems and disposables, which each bring their own technical, clinical and regulatory challenges. Building a new device means you have to invent quite a lot, meaning: interpret regulation and translate it to the device. You need to be confident enough to bring your convictions to the technical group and stand your ground, but also be able to do this in an amicable way.
Your key responsibilities
- Stay updated on changes in regulations and guidelines and develop strategies to ensure compliance
- Provide input and guidance to cross-functional teams regarding regulatory requirements, timelines and strategies for successful market access
- Participate in post-market surveillance activities after market access
- Assist in preparing for and participating in regulatory audits and inspections.
How you will do it
- You have a ‘can do it’ mentality
- You’re a team player
- You love to work on the toughest challenges
- You’ll find cutting-edge solutions
- You strive for excellence in all domains
What you will bring
- At least 5 years of experience in Regulatory Affairs for medical devices, backed with a BSc in a technical or scientific field
- Demonstrable achievements in bringing innovative MedTech products to the market and obtaining regulatory approvals (including CE and preferably FDA), strong knowledge of MDR
- Excellent written English communication skills, in particular strong in regulatory writing. You’re a confident communicator, with a positive - somewhat scientific - mindset, you know how to fail and get back on your feet again
- Experience with and knowledgeable in a multitude of widely used standards such as risk management (ISO 14971), usability (IEC 62366), biocompatibility (ISO 10993), basic safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software development (IEC 62304)
What we offer
- Competitive salary including pension plan
- 24 days of annual leave based on a full-time position
- Stock options, to become ‘co-owner’ of a fast-growing company
- Hybrid work model
- Working together in a high-skilled team with our home base in Utrecht
- Frequent out-of-work activities with our team (such as our Skitestro ski-trip)
- Training budget of €2000
- Opportunity to be key shaper of a new global industry niche: autonomous medical robotics
We offer an environment where you can make a lot of impact, as you are joining a growing scale-up in MedTech. Our team of driven and talented colleagues enjoys solving the challenges in developing, manufacturing, and completing our breakthrough medical device. While working in an open culture, we strive for excellence in all domains. We believe in taking courage and like to challenge each other. We learn and teach, regardless of age, nationality or gender.
Are you excited?
We totally understand that, so are we! By joining us, you can play an active role in changing the future of health care. Excited to join our revolution? Then we’d love to hear from you!
If you think you've got what it takes, but you don't meet all the requirements - we still recommend you apply. We would love to learn about your interest and experience, and consider if you can be a good fit for Vitestro. Nobody is a perfect fit, and we welcome applications with imperfections. We offer a learning environment where we grow together!
For questions, please contact Mandla Malaba, firstname.lastname@example.org.
For recruitment agencies – no thank you.