Quality & Regulatory Affairs Manager – Medical Devices

About the role

Monidor is seeking a Quality & Regulatory Affairs Manager to lead its ISO 13485 quality management system and ensure compliance with the EU Medical Device Regulation for its Class IIb medical device, Monidor Vitals. The role will be based in Oulu and will work closely with product development, software releases, and cross‑functional teams to embed quality and regulatory considerations throughout the product lifecycle.

Key responsibilities

• Maintain and continuously improve the ISO 13485 QMS, including documentation and internal processes.
• Ensure compliance with EU MDR and other applicable regulations.
• Coordinate internal and external audits and act as the primary liaison with notified bodies, authorities, suppliers and external experts.
• Manage CAPAs, non‑conformities, change control and supplier quality activities.
• Support risk management, technical documentation and post‑market surveillance, including vigilance and feedback handling.
• Provide practical quality and regulatory guidance during product development, software releases, and integration of third‑party medical devices, smart algorithms and AI‑assisted reporting.
• Train and support the team on quality‑related matters and participate in cross‑functional development projects.

Required profile

• Proven experience in Quality Assurance and Regulatory Affairs within the medical device industry (ISO 13485, EU MDR).
• Strong understanding of CAPA processes, risk management, change control and supplier quality.
• Ability to work autonomously, guide cross‑functional teams and communicate with external stakeholders.
• Relevant academic background (e.g., engineering, life sciences) or equivalent professional experience.

Required skills

• ISO 13485 quality management system
• EU Medical Device Regulation (MDR) compliance
• CAPA and non‑conformity management
• Risk management and change control
• Technical documentation and post‑market surveillance
• Vigilance reporting
• Software release coordination
• Integration of smart algorithms and AI‑assisted reporting