Regulatory Affairs

Vor 5 Tagen

Berlin, Deutschland DeepSpin GmbH Vollzeit

**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:

- 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.

**Your profile**:
**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 mínimal 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

**Why us?**:
**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 revolutionise 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 (training, 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

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