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.
Work Mode
This is an on-site position based in our office in Freiburg.
Beutler Saghari & Partner GmbH is an equal opportunity employer.
