About the Company

Founded in 2017 in Utrecht, Vitestro is pioneering the future of blood collection with the Aletta® Autonomous Robotic Phlebotomy Device™ (ARPD™). This groundbreaking medical device combines advanced multi-modal imaging, robotics, and AI to perform the diagnostic blood draw procedure autonomously. By addressing critical healthcare staffing shortages and improving patient experience, Vitestro is transforming one of the most common and essential medical procedures. With more than 90 team members and growing rapidly, we are scaling our impact as we place our first devices with customers and expand internationally.

The Role

We are looking for a hands-on Senior Regulatory Affairs Specialist to support Vitestro’s global regulatory strategy and execution as we scale our autonomous robotic medical device across multiple markets. In your first months, you’ll focus on:

• Supporting regulatory submissions and strategy for the U.S. and EU, preparing for market launch and commercialization.
• Managing significant change assessments and regulatory impact assessments across product, software, manufacturing, labeling, and supplier changes.
• Interacting with Notified Bodies and regulatory authorities, including submission responses, audit support, and follow-up actions.
• Partnering with R&D, Quality, Clinical, Operations, and Product teams to embed regulatory requirements into product development and lifecycle processes.
• Monitoring regulatory developments and translating them into practical guidance for the organization.

What You Bring

• MSc or PhD in engineering, healthcare, or life sciences.
• 7+ years of Regulatory Affairs experience in the medical device industry, with demonstrated end-to-end responsibility for regulatory deliverables.
• Excellent verbal and written communication skills, supporting strong organizational capabilities.
• Experience with U.S. FDA (pre-)submissions with a proven track record in obtaining 510(k) clearance.
• Experience with preparing CE Marking submissions and significant changes under the MDR, with working knowledge of relevant standards and regulations.
• Experience with complex, active medical devices.
• Full-time availability, onsite presence in Utrecht at least 3 days per week.

Nice to Have

• FDA De Novo and/or PMA experience.
• Experience leading Notified Body and/or FDA audits.
• Health Canada and/or UKCA/MHRA submission experience.

What We Offer

• Competitive salary including pension plan.
• 25 days of annual leave based on a full-time position.
• Hybrid work model.
• Working together in a highly skilled team with our home base in Utrecht.
• Frequent out-of-work activities and an annual company weekend away.
• Annual training budget of €2,000.
• Opportunity to help shape a new global industry niche: autonomous medical robotics.

We offer an environment where you can make a significant impact as you join a growing MedTech scale-up. Our team enjoys solving the challenges involved in developing, manufacturing, and commercializing our breakthrough medical device. In our open culture, we strive for excellence, challenge each other, and learn and teach regardless of age, nationality, or gender.

Are you excited? We totally understand that and so are we! By joining us, you can play an active role in changing the future of health care. 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!