Regulatory Affairs Manager

At MHS, we envision a world in which everyone understands what is going on in their body and what their body needs in order to live a healthier and better life. In a rising and fast growing healthcare ecosystem we pioneer new software solutions, combining science and tech. We're a diversely skilled team and proud to be supported by medical doctors, leading investors and strong partners in the healthcare industry to achieve our vision for the future of health and wellbeing.

Tasks

• You lead the creation of regulatory required documents and compliance with standards
• You take responsibility for the market approval of our software medical products in international markets
• You take responsibility for the implementation of new regulatory requirements following the
  requirements of the IEC 62304
• You perform external and internal audits

Requirements

• You have successfully completed your studies and have at least 3-4 years of professional experience in the field of regulated product development, preferably software
• Experience in the area of regulatory affairs for software as.a medical device, preferably for approvals in Europe
• You are familiar with the IEC 63204, ISO 13485 & ISO 14971
• You are pragmatic, structured, enjoy writing and are proficient in changing perspectives to meet the needs of the respective stakeholders
• You enjoy working in cross-functional teams and understand digital processes
• Fluent German and business fluent English complete your profile

Benefits

• Work in a fast and strongly growing start-up company
• Assumption of responsibility for product and team
• The opportunity to help shape the company according to your ideas
• A work environment free from bureaucracy and corporate constraints; a culture where your opinion matters and is valued
• A highly motivated and supportive team, with excellent investors