Job Overview
Lead the quality management system for a medical device company specializing in AI-based software for radiology. Play a central role in maintaining high standards, scaling AI solutions globally, and working closely with founders to develop quality strategy while ensuring compliance with international regulations.
Responsibilities
- Drive the implementation, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) according to MDR and ISO 13485.
- Serve as the primary point of contact for quality-related topics within the executive team as Management Representative.
- Coordinate and lead internal and external audits, including communication with Notified Bodies.
- Own the CAPA process, supplier management, employee training, software tool validation, and other processes to ensure organizational excellence.
Qualifications
- Extensive experience in quality management and regulatory affairs within the medical device industry, preferably Software as a Medical Device in Radiology AI.
- Expert knowledge of ISO 13485, MDR (EU) 2017/745, IEC 62304, ISO 14971, ISO 27001, FDA, and MDSAP.
- Ability to define and track OKRs that align with the company’s quality policy and mission.
- Hands-on mindset for defining long-term regulatory strategy and executing administrative tasks to maintain an audit-ready QMS.
- Advocate for ‘Compliance by Design,’ embedding quality and security into the software development lifecycle.
- Profound English skills for reading, writing, and presenting; ability to draft complex, clear compliance documentation.
- Strong belief in team growth and empathy; structured work style with high self-motivation.
- Work permit in EU and open to quarterly or monthly travel.
Bonus Skills
- Experience with regulating or clearing AI-based image analysis solutions in radiology.
- Experience ensuring regulatory compliance in agile software development processes.
- Experience with data and information security topics.
- Experience with JIRA or similar project management tools.
- German, Dutch, or Scandinavian language skills.
