Position Overview

We seek a qualified and driven Director of Quality and Regulatory Affairs, who will serve as the Quality Management Representative (QMB) and Person Responsible for Regulatory Compliance (PRRC). This strategic role ensures that our Quality Management System (QMS) and regulatory processes comply with ISO 13485:2016, EU MDR, and other applicable standards.

As part of the leadership team, you will support the CEO in defining and implementing quality objectives and play a key role in maintaining compliance across product development, production, and post-market surveillance.

Key Responsibilities

As Quality Management Representative (QMB):

• Maintain and continually improve the company’s QMS per ISO 13485
• Plan quality objectives jointly with the CEO and monitor their implementation
• Promote quality awareness and train staff on quality-related topics
• Conduct internal audits and coordinate certification audits
• Monitor quality inspections and manage non-conformities
• Support preventive and corrective action processes
• Evaluate and select suppliers and maintain key manufacturer relationships
• Define testing activities and review QMS effectiveness
• Act as a point of contact for all quality-related matters within the company

As a Person Responsible for Regulatory Compliance (PRRC):

• Ensure compliance with EU MDR for all marketed devices
• Oversee technical documentation and EU declarations of conformity
• Confirm proper conformity assessments before product release
• Ensure post-market surveillance and vigilance reporting (Articles 10(10), 87–91)
• Support documentation for investigational devices when applicable

Required Qualifications

• University degree (e.g., law, medicine, pharmacy, engineering, or other scientific discipline) AND at least 1 year of experience in regulatory affairs or QMS related to medical devices
• In-depth knowledge of ISO 13485, EU MDR, and medical device regulatory frameworks
• Independent, well-organized, and reliable work ethic
• Strong interpersonal and communication skills; team player
• Proficiency in Microsoft Word and Excel
• Strong analytical and problem-solving abilities
• Fluent in English; proficiency in German is a strong asset

What We Offer

• A key leadership position in a growing biotech company at the forefront of oncological innovation
• A flexible hybrid work arrangement (50–80% on-site/remote)
• Opportunities to shape quality and regulatory strategy in a niche therapeutic field
• A collaborative, innovation-focused team culture
• Competitive compensation and benefits