TL;DR

Senior Healthcare Regulatory Specialist (SaMD): Ensuring Docplanner meets regulatory requirements, focusing on EU MDR compliance and global expansion. Focus on building a robust governance framework, risk mitigation, and process optimization in the digital healthcare industry.

Location: Remote-friendly within Spain

Company

Docplanner Group is the world’s largest healthcare platform, connecting 24 million patients with 280k doctors across 13 countries monthly.

What you will do

  • Achieve mandatory Medical Device Regulation certification to maintain European market access.
  • Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance.
  • Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence.
  • Prevent regulatory fines and reputational harm that could impact the ability to serve patients and healthcare providers.
  • 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.
  • 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.

Culture & Benefits

  • Access to healthcare insurance.
  • Wellness programs from gym memberships to mental health support.
  • Flexible time off policy.
  • ESOP (Employee Share Option Plan) after 6 months.
  • Remote work and flexible hours.

Hiring process

  • Intro chat with Talent Partner.
  • Business Case take-home exercise.
  • Technical interview.
  • Operational Interview.
  • Final Interview.