Beutler Saghari & Partner GmbH is hiring a Global Head QM/RA (m/w/d) to provide strategic leadership for Quality Management and Regulatory Affairs within our medical technology company. This key role shapes our quality systems and international market access.

What You'll Do

Provide strategic direction for the Quality Management area.
Establish, maintain, and continuously develop the Quality Management System according to ISO 13485 and MDR.
Manage and execute internal and external audits, including supplier and authority audits.
Coordinate complaint management, CAPA processes, and risk-based market surveillance.
Own responsibility for international product registrations and technical documentation.
Lead, develop, and hire for the QM team.

What We're Looking For

A completed university degree in medical technology, natural sciences, engineering, or a comparable qualification.
Several years of professional experience in Quality Management and Regulatory Affairs within the medical technology sector.
Proven leadership experience.
In-depth knowledge of international standards and regulations, specifically ISO 13485 and MDR.
Fluent German and English language skills.
Strong communication skills.

Nice to Have

Knowledge of FDA regulations.

Benefits & Compensation

Work in a highly modern, innovation-driven environment with a clear vision.
Considerable scope for design and personal responsibility in a key position.
DUZ culture and Open Door Policy ensure flat hierarchies and short decision-making paths.
Opportunities for personal and professional development for long-term company affiliation.