RAQA Manager

THE COMPANY

A fast-growing DeepTech medical devices company developing innovative AI-powered and robotic-assisted solutions for critical healthcare applications.

The company operates in a highly regulated and innovative environment, combining medical expertise, cutting-edge technology, advanced algorithms, and regulatory excellence to transform clinical practice.

THE OPPORTUNITY

We are seeking an experienced Quality & Regulatory Affairs Manager to take ownership of quality and regulatory strategy for innovative AI-powered and robotic medical devices.

This role is critical to:

• Build and scale regulatory submissions for multiple markets (EU, US, and beyond)
• Establish a robust Quality Management System aligned with ISO 13485 and MDR 2017/745
• Navigate the complexity of AI/software medical device regulation
• Act as a strategic partner to R&D and leadership teams
• Lead the organization toward regulatory excellence

This is a hands-on and strategic role, ideal for someone comfortable in a high-growth environment and eager to make a real impact.

RESPONSIBILITIES

Quality Management System:

• Implement, maintain, and continuously improve the QMS in compliance with ISO 13485 and MDR
• Define and monitor quality planning
• Manage the document control system and ensure alignment
• Analyze quality performance indicators
• Organize and lead management reviews??
• Promote a quality culture and deliver training
• Ensure compliance of design, industrialization, and manufacturing
• Review R&D deliverables and technical documentation
• Participate in risk management activities (ISO 14971)
• Ensure product compliance prior to market release

Quality Oversight & Compliance:

• Oversee CAPA, non-conformities, complaints, change control
• Lead internal and supplier audits
• Coordinate inspections and manage regulatory responses
• Support supplier qualification
• Ensure regulatory and standards monitoring

Regulatory Affairs:

• Define regulatory strategy for target markets
• Lead preparation of regulatory submissions (CE, FDA)
• Manage interactions with regulatory authorities
• Ensure regulatory registrations (EUDAMED, ANSM)

REQUIREMENTS

Must-have:

• Strong expertise in EU MDR 2017/745, 21 CFR, ISO 13485, AI/software standards
• Proven experience bringing Class IIb+ devices to EU/US market
• Minimum 4-8 years in medical device quality & regulatory
• Background in software medical devices and digital health
• Strong writing and documentation skills
• Experience as Regulatory Affairs or QMS Representative

WHY JOIN?

• Work on cutting-edge AI and robotic medical devices with real clinical impact
• Shape regulatory strategy at a critical growth stage
• High level of autonomy and responsibility
• Direct interaction with R&D, clinical teams, and leadership
• Opportunity to grow in a fast-scaling DeepTech organization
• Meaningful role at the intersection of innovation, regulation, and patient safety
• Competitive compensation and flexible work environment