Job Description

Senior Healthcare Regulatory Specialist (SaMD) for Docplanner Group’s Risk & Compliance team. Act as Person Responsible for Regulatory Compliance (PRRC) under EU MDR, partner with Product, Engineering, Machine Learning, Data, Customer Care and Legal to ensure SaMD products meet regulatory requirements across Europe.

How you will make an impact

• 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.
• Build compliant governance framework, risk mitigation, process optimization.
• Prevent regulatory fines and reputational harm.

Qualifications

• Strong knowledge of EU MDR, especially SaMD.
• Experience in medical device regulatory affairs, QMS, and regulatory governa...