About DeepSpin

DeepSpin is a HealthTech startup pursuing the mission to make Magnetic Resonance Imaging universally accessible. Today 7 out of 10 people globally do not have access to this life-saving imaging modality. Through our cutting-edge technology we are going to change that. Backed by globally leading VCs, we are now expanding our world-class team. This is a fantastic opportunity to join a team motivated to bring a life-saving technology to the billions of people that currently cannot afford it.

Join us in developing game-changing technology!

About the Role

As a Regulatory Affairs & Quality Assurance Manager you will drive the medical device certification of DeepSpin's MRI-system in US & Europe and continuously improve our quality management system.

Your responsibilities are:

• Drive CE class IIa medical device certification and FDA 510(k) process
  • Creation and maintenance of technical documentation
  • Coordination with notified bodies and regulatory bodies
  • Coordination and management of all required testing
  • Conducting risk management (ISO 14971)
• Define, implement and continuously improve all processes of QMS in line with ISO 13485 and FDA
• Conduct a comprehensive gap analysis to identify areas needing improvement, such as regulatory and quality training requirements, and implement corrective actions.
• Develop streamlined processes for incorporating clinical testing into the QMS, defining what specific data must be reported and how this should be outputted in final submission documents.
• Collaborate in designing a simplified reporting infrastructure, focusing on regulatory needs while maintaining effective and manageable documentation processes.

About You:

• Successfully completed studies in life science, engineering or similar
• 5+ years of relevant experience in the field of regulatory
• Successfully brought a class II medical device through FDA 510(k) and CE certification
• Experience in the implementation of a Quality Management System and deep knowledge of ISO 13485
• Experience engaging with notified bodies and competent authorities
• Technical understanding and/or strong interest in MRI and A.I.
• Highly motivated self-starter who can establish a course of action with minimal guidance
• Demonstrated time management, organizational skills, detail-orientation and a strong commitment to personal and organizational accountability
• Excellent written and verbal communication skills
• Accreditation as an auditor - preferred
• Training and/or experience as a risk manager (ISO 14971) - preferred
• Experience with clinical evaluations - preferred

What we offer:

• Dynamic & Innovative Culture: A creative workplace with flat hierarchies and open communication among a highly skilled collaborative team
• International environment: A diverse and multicultural English-first office with more than 10 different nationalities driven by the same purpose, to revolutionize medical imaging
• Benefits: Urban Sports Club, BVG and lifestyle vouchers along with company-sponsored lunch in our penthouse office and monthly team events
• Personal development: In addition to learning on the job through mentorship and high responsibility from the start, we encourage and support personal development (trainings, certifications etc.).
• Work-life balance: 30 days of paid leave per year and Parental leaves
• Relocation: Support with visa and relocation as well as with finding daycare for your children