AOT is a strongly growing Swiss MedTech company dedicated to the development of robotic laser osteotomes and novel surgical workflows that will revolutionize the field of bone surgery. To enable our targeted growth trajectory, we are currently seeking a qualified
Senior Regulatory Affairs Manager
You will directly report to the Chief Quality Officer and you will apply your profound knowledge in the field of international regulations and standards for medical devices.
Duties and Responsibilities:
Performing medical device and company registrations internationally in a timely manner
Providing reliable regulatory guidance in development projects
Creation and maintaining of product-specific technical documentations
Ensuring compliance with all regulatory requirements
Leading vigilance tasks, such as Adverse events, Field Safety Corrective Actions, etc.
Ensuring up-to-date knowledge in quality and product relevant standards, laws and guidelines
Provide regulatory inputs for the quality management system
Beside your ability to work in a small high-tech team, you take the personal responsibility and show willingness to learn; the ideal candidate should meet the following criteria:
Bachelor or master’s degree in engineering (electronics, mechanical, software) preferred
Good knowledge of the relevant medical regulations and standards like MDR, EN ISO 13485, FDA 21 CFR Part 820, EN ISO 14971, EN IEC 60601-1, EN ISO 62366-1 etc.
Experience in a similar role in a small company
Experience in submissions for the EU required, others, like FDA would be an asset
Amicable, hands on, open minded, good listener, solution provider
Very good understanding of complex technical systems
Analytical mind and systematic working
Good command of English orally and in writing required, German would be an asset
We offer a competitive compensation and flexible working conditions. We are a young and dynamic company with flat hierarchies where your input makes a difference.
Your working location will be in the center of Basel (5 minutes’ walk from Basel SBB).
We are a young and dynamic company with flat hierarchies where your input makes a difference. You will shape the world’s first laser osteotome and change the way surgery is done in the future. Your working location will be in the center of Basel (5 minutes’ walk from Basel SBB).