Head of Regulatory Affairs & Quality Assurance (m/f/d)

Berlin, Germany

Head of Regulatory Affairs & Quality Assurance

About DeepSpin

DeepSpin is a HealthTech startup pursuing the mission to make Magnetic Resonance Imaging universally accessible. Today 9 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.

About the Role

As Head of Regulatory Affairs & Quality Assurance you will lead the medical device certification of DeepSpin's MRI-system in Europe and in the US and implement and continuously improve our quality management system. Your responsibilities are:

  • Lead 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 (Design controls, corrective and preventative actions, Records, documents and change, Equipment & facility controls, Material controls, Production & process controls, Management control)
  • Continuously coordinate and collaborate closely with engineering and product team to ensure regulatory compliance
  • Contribute with regulatory expertise to strategic decisions such as market entry in other countries

Ideally you have

  • Successfully completed studies in life science, engineering or similar
  • 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:

  • The opportunity to truly make a difference in the world by shaping a ground-breaking product early on
  • High responsibility and learning from day one
  • A diverse and multicultural English-first office
  • A creative workplace with flat hierarchies and open communication
  • Working directly with the founders and a world-class team of advisors supporting us (Leading Professors, entrepreneurs and investors)
  • A 55.000-75.000€ salary, a competitive stock package and 30 days of yearly vacation
  • A great penthouse office in the center of Berlin, company-sponsored lunch every day, a company laptop and beers on Friday!

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