Senior Project Manager

About Qardio

We are a great team on an even greater mission: we believe our innovative solutions will revolutionize healthcare around the world. We come to work every day to solve problems, face challenges, and improve the lives of millions. And we have fun along the way.

Qardio is big enough to matter but small enough to make you matter too. If you are driven and ambitious, want to have a great job along with other great people, and want to make a difference, please apply.

Position

• Be responsible for the organization, documentation, and maintenance of the quality system to be compliant with, as appropriate, the following standards: ISO 13485, CFR Part 820/211, and other applicable standards
• Manage the product planning and launch process for new service propositions, working within a multi-functional team
• Serve as the primary point of contact with all the stakeholders
• Develop recommendations for strategic projects

Your qualification

• Degree in science, medical or technical field and 5-7 years of professional experience in regulatory affairs or in quality management systems relating to medical devices
• Experience implementing ISO 13485 Quality Management Systems
• Strong knowledge of ISO regulations and procedures for medical devices and FDA and CE Certifications 
• Have the ability to read, analyze, and interpret standards and regulations
• Have the ability to execute quickly, in an intense, delivery-focused environment
• Have a global mindset and be happy operating in multiple time zones
• Possess exceptional collaboration and relationship-building skills across functional teams
• Be driven by a hunger for challenge and opportunity and thriving in a fast-paced environment
• Have a thorough technical understanding of IT development processes
• Have a proven track record for managing multiple projects at once
• Be passionate about digital health

What we offer

• The ability to control your own career path and grow into a leadership role with an innovative company
• Great working environment, flexible work hours, holiday plan, 25 days of leave yearly, hackathons, and training 
• The ability to participate in a cutting-edge field of creating digital healthcare products
• The opportunity to work in an international environment with colleagues from different cultures, countries, and backgrounds
• Visa sponsorship