Role Overview
This position is responsible for ensuring regulatory compliance for software-based medical devices under the European Union Medical Device Regulation (MDR). As the designated Person Responsible for Regulatory Compliance (PRRC), you will play a central role in maintaining legal market access and advancing the company’s commitment to safe, trustworthy healthcare innovation.
Key Responsibilities
- Serve as the official PRRC in accordance with EU MDR requirements
- Collaborate with Product, Engineering, Data Science, Legal, and Customer Care teams to embed compliance into product development
- Lead certification efforts for MDR and other relevant standards such as ISO and C5
- Support entry into new markets by managing global regulatory approvals
- Develop governance frameworks that ensure transparency, accountability, and trust
- Proactively identify and address compliance risks to avoid penalties and protect patient safety
- Continuously refine regulatory processes to align with changes in digital health policy and technology
Qualifications
Required
- Documented experience serving as PRRC under EU MDR
- Thorough knowledge of EU MDR, particularly as it applies to Software as a Medical Device (SaMD)
- Proven track record in regulatory affairs for medical devices or digital health products in Europe
- Ability to coordinate across technical, legal, and commercial functions
- Solid grasp of digital health compliance frameworks and governance models
Preferred
- Experience with ISO standards and cybersecurity certifications such as C5
- Background in AI-enabled or advanced health technologies
- Exposure to international regulatory strategies in highly regulated sectors
- Familiarity with risk management in healthcare compliance programs
Work Environment
This role is remote-friendly for candidates based in Spain. You’ll contribute to a globally distributed effort while supporting scalable, compliant, and patient-centered digital health solutions. The position offers direct influence over regulatory strategy and the chance to shape best practices in an evolving industry.
