Senior Regulatory Affairs Manager


Offered by:


Creative / Design

You will directly report to the Chief Quality Officer and you will apply your profound kledge 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 kledge in quality and product relevant standards, laws and guidelines
  • Provide regulatory inputs for the quality management system

Your Skills: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
  • od kledge 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
  • Analytical mind and systematic working
  • od command of English orally and in writing required, German would be an asset
  • Amicable, hands on, open minded, good listener, solution provider
  • Very good understanding of complex technical systems

Your benefits: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).