Beschreibung
For our medical device AI software, we are looking for an experienced person who will continue and lead our quality management and maintain our regulatory affairs.
Your role
- Responsibility for the company's quality management
- Responsibility for extending, maintaining, and certifying our eQMS according to ISO 13485
- Facilitating internal audits and inspections by notified bodies, authorities, and customers
- Planning and controlling onboarding of new employees
- Conducting regular training on quality management with employees
- Adapting our QM system to new markets and requirements
- Responsibility for our organization and products to meet legal requirements, regulations and standards
Your qualifications
- Completed technical or scientific training at HF, technical college or university
- Three or more years of professional experience in Quality Management (ISO 13485, MDR, CFR 21 Part 820, MDSAP), relating to medical devices of class II or higher
- Appropriate regulatory management experience (510(k), de novo, CE Mark) in an area with a lot of regulatory uncertainties (cloud, artificial intelligence, machine learning) is a strong plus
- Experience with software development and the testing of software is a plus
- Appropriate management experience (preferably as an auditor or QM officer)
- Ability to work independently in a fast-paced environment, managing multiple, competing priorities
- Ability to quickly get into and learn the necessary skills for new tasks/challenges
- Strong communication and organizational personality with leadership and teamwork skills
- Business fluency in English (spoken and written). German is a plus.
- Swiss or EU/EFTA work permit
What we offer
- Collaborative modern workspace environment with abundant medical data to be explored and turned into value for healthcare providers
- Contribute to a highly innovative medical AI software device
- High impact on the company's achievements in direct collaboration with the leadership team
- Flexible work times and hybrid work scenarios