Regulatory Affairs & Quality Assurance Specialist (m/f/d) (Full Time/Part Time)

Your mission

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 Specialist 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:

1. Drive CE class IIa medical device certification and FDA 510(k) process
2. Creation and maintenance of technical documentation
3. Coordination with notified bodies and regulatory bodies
4. Coordination and management of all required testing
5. Conducting risk management (ISO 14971)
6. Define, implement and continuously improve all processes of QMS in line with ISO 13485 and FDA
7. Conduct a comprehensive gap analysis to identify areas needing improvement, such as regulatory and quality training requirements, and implement corrective actions.
8. 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.
9. Collaborate in designing a simplified reporting infrastructure, focusing on regulatory needs while maintaining effective and manageable documentation processes.

Your profile

About You:

1. Successfully completed studies in life science, engineering or similar
2. 5+ years of relevant experience in the field of regulatory
3. Successfully brought a class II medical device through FDA 510(k) and CE certification
4. Experience in the implementation of a Quality Management System and deep knowledge of ISO 13485
5. Experience engaging with notified bodies and competent authorities
6. Technical understanding and/or strong interest in MRI and A.I.
7. Highly motivated self-starter who can establish a course of action with minimal guidance
8. Demonstrated time management, organizational skills, detail-orientation and a strong commitment to personal and organizational accountability
9. Excellent written and verbal communication skills
10. Accreditation as an auditor – preferred
11. Training and/or experience as a risk manager (ISO 14971) – preferred
12. Experience with clinical evaluations – preferred

Why us?

What we offer:

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

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