Senior Regulatory & Quality Lead / PRRC (MDR / ISO 13485)

About the role

QUMEA is a Swiss MedTech company developing radar‑based, contactless patient monitoring solutions. We are looking for a senior professional to own the EU Medical Device Regulation (MDR) compliance process, act as the Person Responsible for Regulatory Compliance (PRRC), and lead our ISO 13485 quality management system.

Key responsibilities

• Manage end‑to‑end MDR compliance, including classification, technical documentation, registration and Notified Body interactions for Class I and upcoming Class IIa SaMD.
• Serve as the PRRC under MDR Article 15, ensuring conformity checks, up‑to‑date declarations, and post‑market surveillance obligations.
• Build, operate and continuously improve the ISO 13485 QMS, making it scalable, audit‑ready and aligned with daily workflows.
• Plan and execute internal and external audits, and own the CAPA process.
• Integrate ISO 13485, MDR and ISO 27001 into a single governance and risk framework, collaborating closely with the CIO/PRRC.
• Lead risk management activities in line with ISO 14971 and related standards.
• Drive change management across engineering, sensor commissioning, sales and other functions to embed compliant processes without slowing innovation.

Required profile

• Extensive experience with EU MDR (2017/745) and ISO 13485 implementation in medical device companies.
• Previous role as a PRRC or equivalent regulatory compliance authority.
• Proven ability to lead cross‑functional change initiatives in fast‑moving, AI‑first environments.
• Strong understanding of ISO 27001 information‑security requirements and their interaction with quality and regulatory systems.
• Excellent communication skills to influence teams and external partners.

Required skills

• MDR (EU 2017/745) compliance
• ISO 13485 quality management
• ISO 27001 information security
• Risk management (ISO 14971)
• CAPA and audit management

What we offer

• Dynamic startup environment with a strong focus on AI‑driven processes.
• Opportunity to shape regulatory and quality strategy for innovative medical devices.
• Competitive compensation package.