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DocPlanner GmbH Logo DocPlanner GmbH · Health and Beauty

Senior Healthcare Regulatory Specialist (SaMD)

Spain, Barcelona · Job Posted January 15, 2026

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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.

Job Responsibility

  • 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

Requirements

  • 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

Nice to have

  • Knowledge of the EU AI Act
  • Familiarity with Agile / software development environments
  • Spanish or other EU languages are a plus

What we offer

  • Healthcare insurance
  • Wellness that works for you – from gym memberships to mental health support
  • Time off that counts – whether it’s a vacation, your birthday, or just a day to recharge
  • ESOP (Employee Stock Option Plan) after 6 months
  • 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 – chances to learn, develop, and explore new paths
  • 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
  • Office access at hubs in Barcelona, Warsaw, Curitiba, Rio de Janeiro, Mexico City, Bogotá, Munich, Rome or Bologna
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