Docplanner is hiring a Senior Healthcare Regulatory Specialist (SaMD) to serve as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR. In this role, you will partner with cross-functional teams to ensure our Software as a Medical Device products meet regulatory standards across Europe, enabling safe, compliant, and scalable operations.

What You'll Do

Achieve mandatory Medical Device Regulation (MDR) 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 our 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.

What We're Looking For

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

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

Team & Environment

You will be part of the Global Risk & Compliance team, partnering with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams.

Benefits & Compensation

Healthcare insurance.
Wellness benefits (gym memberships, mental health support).
Generous time off policy.
ESOP (Employee Stock Option Plan) after 6 months.
Local perks like meal vouchers (ticket restaurant), transport allowances, or extended parental leave depending on location.
Career growth opportunities and cross-functional projects.
Flexible work arrangements.

Work Mode

This is a remote-friendly position for candidates based within Spain.

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.