Quality and Regulatory Manager (m/f/d)

Are you a reliable and analytically thinking personality who inspires through team play and assertiveness? Do you have a can-do attitude and entrepreneurial thinking? Great, then we should get to know each other!

We are looking for a Quality and Regulatory Manager for our headquarters in Munich. In your role you will gain exciting insights into our digital medical product and furthermore into the broad field of telemedicine - one of the currently fastest growing markets in Germany and Europe.

With your support you will help our entire team to develop medical device software at the highest quality level and attain MDR specification for our software medicinal product. Within this framework, you will be responsible for planning and organizing measures for the approval of software-based medical devices under consideration of EU-wide requirements. You are also the central contact person for internal and external stakeholders, such as top management, medical development partners, service providers, notified bodies or other approval partners.

Tasks

• Maintenance of a QMS according to ISO 13485/MDR
• Contact person (m/f/d) for quality management and regulatory requirements
• Compliance with legal standards and guidelines regarding quality management in the field of medical devices
• Planning and execution of internal and external audits
• Preparation and maintenance of the approval documents and corresponding internal and external coordination with the regulatory authorities
• Assumption of the function as Responsible Person (PRRC) for compliance with the regulatory requirements according to the Medical Device Regulation (MDR)

Requirements

• Ideally, several years of professional experience as a QMB in medical device companies
• Good knowledge of Microsoft Office, ideally Office 365 and SharePoint
• Knowledge of MDR, ISO 13485 and corresponding standards
• Ability to work in a team and strong communication skills, coupled with initiative and analytical thinking
• Independent way of working
• Good project management skills
• Very good language skills in German or English

Benefits

• A highly motivated, international team, a varied job and the explicit wish to you to proactively contribute your ideas
• A permanent position and flexible working hours
• A modern workplace in the heart of Munich
• Regular team events
• Annual budget for further education
• A positive error culture, flat hierarchies and direct communication among each other

Does that sound exciting? Then don't hesitate and apply now!

We look forward to meeting you in person!