QARA Specialist

About MindMaze Therapeutics

MindMaze 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, MindMaze 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.

The role

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.

Key responsibilities

• 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.

Qualifications

• 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 MatrixReq),
• Fluent in English (level C1) with minimum B2 level in French.