Job Description

Job Description

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 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):

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

    2️Business 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.

    3️ 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. 

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

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

    6️ 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 Share 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? You're 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  we're 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.

    Apply for this Position

    Ready to join ? Click the button below to submit your application.

    Submit Application