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 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 Docplanners core strategic priorities: EU MDR compliance and global expansion. Youll 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.

Qualifications :

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.

Additional Information :

What to Expect from Our Hiring Process 

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

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

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

3 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 mindits just as much about making sure were the right fit for you too. 

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

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

6 References & Offer!

Why Youll Love It Here

Global Benefits  No matter where you are youll have access to:

• Healthcare insurance so you can focus on what matters.
• Wellness that works for you from gym memberships to mental health support weve got you covered.
• Time off that counts whether its a vacation your birthday or just a day to recharge we believe in balance.
• ESOP (Employee Stock Option Plan) after 6 months with usbecause we believe in sharing our success!

Local Perks  Depending on your location you will be entitled to local benefits like meal vouchers (ticket restaurant) transport allowances or extended parental leave.

Career Growth  Were growing and so can you! Youll find lots of chances to learn develop and explore new pathswhether within your team or through cross-functional projects.

A Truly Global Team  Work with talented people from all over the world in a diverse and inclusive environment.

Flexibility That Works for You  Remote work and flexible hours arent just buzzwords here. While the extent of flexibility depends on your role and team we value results over rigid schedules. Prefer an office setting Youre welcome at any of our hubs in Barcelona Warsaw Curitiba Rio de Janeiro Mexico City Bogotá Munich Rome or Bologna.

Please note: At this time we are not able to sponsor visas for this position. To apply you must already have the legal right to work in your country of residence or the location of the role.

What We Believe In 

At Docplanner our values guide everything we do:

Focus on results  were here to make an impact.

Think like an owner  take responsibility drive outcomes.

Keep it simple keep it lean  smart solutions over complexity.

Be respectful and radically honest  openness builds trust.

Learn and be curious  growth is part of the job.

Dont just take our word for itcheck out our Glassdoor to hear what our people say!

We are committed to building a team that represents a variety of backgrounds perspectives and skills. We welcome applicants from all walks of life regardless of gender disability or background and are dedicated to fostering an inclusive workplace where everyone feels valued and empowered to contribute.

Remote Work :

No

Employment Type :

Full-time