Regulatory Affairs Specialist – Medical Devices (SaMD)
UpHill HealthLisbon, Portugal
Posted January 12, 2026
Full Time
About the Company
UpHill is a mission-driven team shaping the future of healthcare through clinical pathways and care orchestration software.
Job Description
Regulatory Affairs Specialist – Medical Devices (SaMD) responsible for building, owning and operating the regulatory and quality framework for UpHill, a company revolutionizing healthcare through clinical pathways and care orchestration software. Key responsibilities include ensuring compliance with EU MDR, UKCA, and FDA requirements, maintaining technical files and documentation, and leading audits.
Requirements
- 3+ years of experience in Regulatory Affairs, Quality or Compliance in a medical device company
- Practical experience with EU MDR, ISO 13485, technical documentation and audits
- Eligibility (or a clear path) to act as PRRC (Person Responsible for Regulatory Compliance)
- Experience working with NBs (Notified Bodies)
- Comfortable working with engineers and product teams
- Fluent English
Benefits
- Competitive salary
- Flexible work options
- Comprehensive health insurance
- Top-tier equipment – new PC plus budget for peripherals
- A no-BS culture built on trust, impact, and collaboration
