Regulatory affairs manager állások, munkák egészségügy, gyógyszeripar területen

Regulatory Affairs ManagerMyLife Diabetes Care AG is a new, independent medtech company specialising in the treatment of diabetes using advanced insulin pump systems. To strengthen our Quality Management department, we are looking for a very experienced person on a high seniority level for our...

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams