Quality & Regulatory Operations Manager – Company-wide Compliance

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 and embed our company‑wide quality and regulatory framework, ensuring that compliance becomes a daily habit across all teams as we scale.

Key responsibilities

• Operate, evolve and scale the ISO 13485 Quality Management System (QMS) to be audit‑ready and reflective of real work processes.
• Lead MDR and regulatory governance, manage certifications, and act as the internal authority on medical device regulations.
• Plan, conduct and follow‑up internal and external audits; own the CAPA process.
• Implement risk management per ISO 14971 and integrate it into decision‑making.
• Oversee supplier qualification and collaborate on ISO 27001 information‑security governance.
• Design and drive change‑management processes, creating clear documentation and guiding teams to work compliantly.
• Set and run the compliance cadence – monthly, quarterly and annual review cycles.

Required profile

• Senior quality and regulatory professional with deep knowledge of MDR and ISO 13485.
• Proven track record of successfully passing Notified Body audits and ISO 13485 certifications.
• Hands‑on experience implementing QMSs and leading risk‑management activities.
• Strong change‑management skills with the ability to influence cross‑functional teams.

Required skills

• ISO 13485
• MDR (Medical Device Regulation)
• ISO 14971 (Risk Management)
• ISO 27001 (Information Security Management)
• CAPA management
• Audit planning and execution

What we offer

• Opportunity to shape compliance in a fast‑growing MedTech startup.
• Collaborative, mission‑driven environment focused on innovative patient monitoring.
• Competitive compensation package.