Medical software scale-up is looking for an experienced

QUALIFICATIONS & EXPERIENCE

• You are experienced in the implementation and application of European medical device regulations, ideally with a background in medical device software
• You have a pragmatic mindset to implement regulatory requirements in a practical and efficient way
• You have excellent communication and writing skills in English and German
• You are willing to jump in at the deep end on day one as integral part of the leadership team

• Management and oversight of our overall quality management and regulatory activities
• Develop and maintain our quality management system for compliance with the regulatory requirements
• Coordinate and actively drive company procedures and documentation to ensure compatibility with MDR
• Oversee post-market surveillance activities
• Conduct internal audits and manage external audits
• Be the contact person for our notified body and competent authorities
• Support our internationalization activities with a regulatory and quality management view