QARA Specialist

Mind Maze Therapeutics, a publicly listed, innovative scale‑up headquartered in Switzerland, at the forefront of neuro‑therapeutics and digital brain health solutions. Operating in a regulated medical device environment, Mind Maze Therapeutics is dedicated to developing cutting‑edge technology that supports neurological recovery and treatment.

As the company continues to grow and expand its specialized activities, we are looking for a dedicated Quality Assurance and Regulatory Affairs expert to support compliance, maintain quality systems, and help ensure that products and processes meet applicable regulatory requirements.

As a QARA Specialist, you will play a key role in maintaining, improving, and ensuring compliance of the company’s QMS in accordance with applicable regulatory requirements (FDA, MDR, ISO 13485). You will support cross‑functional teams by providing quality expertise and driving continuous improvement.

Being part of a small team in a scale‑up environment, you will have the opportunity to share your expertise and support the company’s growth.

• Continuously improve QMS by analyzing quality KPIs and data (e.g. complaints, non‑conformances, CAPAs), identifying trends, and proposing corrective and preventive solutions to quality or compliance issues,
• Oversee document lifecycle management, including document creation, review, approval, change control, and archival through the Document Change Request (DCR) process,
• Plan, coordinate, and manage internal and external quality audits, including preparation, execution, follow‑up, and closure of audit findings,
• Prepare, contribute to, and follow up on Management Review activities,
• Deliver Quality Assurance training across the organization to promote awareness and effective application of quality concepts, tools, and procedures,
• Lead Supplier quality management activities,
• Support qualification and validation activities, including the investigation and resolution of deviations and exceptions.
• Proactively identify and implement best‑in‑class QA practices aligned with regulated industry standards and company needs,
• Provide day‑to‑day support for quality system processes, ensuring consistent application of QMS requirements and best practices.
• Provide support for customer complaints.

In addition, you could contribute to the regulatory affairs by:

• Performing regulatory intelligence and regulatory watch, monitoring changes in applicable regulations, standards, and guidance, assessing their impact, and supporting implementation within the company,
• Supporting the maintenance and update market registrations and regulatory submissions in applicable geographies, ensuring ongoing compliance throughout the product lifecycle.

• Bachelor’s or master’s degree in an Engineering, Life Sciences, Quality, or a related discipline,
• Minimum 2 years of experience in Quality Assurance within a regulated industry, preferably medical devices,
• Practical knowledge of regulatory frameworks including EU MDR, FDA QMSR, ISO 13485, and relevant standards (IEC 62304, ISO 14971, IEC 62366),
• Experience supporting internal and external audits, including regulatory inspections and certification audits,
• Experience in regulatory affairs is a plus,
• Excellent organizational and communication skills, with the ability to work effectively in cross‑functional teams,
• Proficiency with quality and business tools (e.g. Microsoft Office, document management systems, and QMS software such as Matrix Req),
• Fluent in English (level C1) with minimum B2 level in French.