Sr. Quality Management and Regulatory Affairs Manager
A Berlin based start-up that is truly changing the dental industry is searching for a Sr. Quality Management and Regulatory Affairs Manager.
You will have a major impact, shaping the company through your own expertise. Together the team brings years of academic research in the Dental industry. The team is made up of engineers, scientists, entrepreneurs, and physicians from one of the world's leading hospitals.
In this role you will plan and execute our strategy for certifying our medical software successfully to multiple International markets.
- Create and continuously improve our Quality Management System
- Write technical documentation (together with our engineering team) for CE certification
- Help identify potential risks and raise awareness for safety concerns
- Plan and manage the CE certification of our medical devices along with potential other markets
- Collaborate with European legislators to improve best practices for the healthcare products containing artificial intelligence
- Practical experience of at least 3 years in computer science or a related Medical Device
- Business fluent in the English and German language
- Experience with Office Software
- Open-minded and communicative
- MSc or PhD in business, computer science or a related field
- Experience with Quality Management Systems according to ISO 13485
- Instruct, contribute to, and review the writing of technical documentation of our medical device products
- Related industry experience for certifying a product
- Experience with testing software or quality assurance techniques
You can expect the following:
- Competitive Salary
- On-the-job training / educational courses: Certifying these products is a very new field. We cover all training for you to develop skills/knowledge.
- Work within a good network of medical and regulatory experts
- Flexible working hours
- Home Office possible