Senior Healthcare Regulatory Specialist (saMD) - (Remote-friendly within Spain)

The Risk & Compliance team ensures Docplanner meets regulatory requirements while supporting safe, scalable, and innovative healthcare solutions. As our products increasingly transition into medical device territory, regulatory compliance is a core enabler of our growth, trust and ability to operate globally.

We are hiring a Senior Healthcare Regulatory Specialist (SaMD) to join our global team. In this role, you will act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR), partnering closely with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams to ensure our Software as a Medical Device (SaMD) products meet regulatory requirements across Europe. You will play a key role in enabling Docplanner to operate safely, compliantly and at scale in an increasingly regulated digital healthcare environment. 

This is a new and highly impactful opportunity, where you will help build and strengthen our regulatory framework, directly supporting one of Docplanner’s core strategic priorities: EU MDR compliance and global expansion. You’ll gain exposure to innovative healthtech and AI-driven products, work with cross-functional teams across multiple markets. 

How will you make an impact?

• EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access. 
• Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance.
• Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence.
• Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers.
• Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry.

What will help you thrive?

• Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context.
• Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks.
• Relevant academic background (law, medicine, pharmacy, engineering, or scientific field)  or the equivalent hands-on experience in medical device regulatory/QMS experience.
• Experience with EUDAMED, CAPA systems, and post-market surveillance tools.
• Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders.
• Strong communication skills with both internal teams and external regulatory authorities.
• Fluent in English; Spanish or other EU languages are a plus. 

Nice to have:

• Knowledge of the EU AI Act.
• Familiarity with Agile / software development environments.

The position is based in Spain and we are remote-friendly.

What to Expect from Our Hiring Process 

We like to keep things transparent and efficient! Here’s what the process usually looks like (though it might vary slightly depending on the role):

1️⃣ Intro Chat – A first call with our Talent Partner Giuliana to explore mutual fit around relevant skills, value alignment, and motivation. 

2️⃣Business Case – A take-home exercise with dedicated prep time, designed to understand how you approach real-life problems and think through regulatory scenarios. You’ll then walk us through your approach in a collaborative discussion with the hiring manager and the team.

3️⃣ Technical Interview – A deeper conversation about your background, aspirations, and experience with EU MDR and compliance, with Siobhon Custodio (your potential manager) and Thayla Banks. Take this chance to ask anything on your mind—it’s just as much about making sure we’re the right fit for you, too. 

4️⃣ Operational Interview –  A discussion with Boróka Kupper and Massimo Belloni, focused on operational fit, QMS integration and how you collaborate with cross-functional teams

5️⃣ Final Interview – A final chat with Karol Traczykowski, focused on cultural fit, values and strategic alignment.

6️⃣ References & Offer!...