Regulatory Affairs and Quality Assurance Specialist

About DeepSpin

Currently, 70% of people worldwide lack access to life-saving Magnetic Resonance Imaging (MRI) due to the high cost and size of traditional MRI machines, which require specialized rooms and are usually found only in large hospitals. DeepSpin is revolutionizing this by developing the world's first Flatbed MRI system—a compact, open-architecture scanner that plugs into a standard outlet, fits in regular doctor's offices, and costs ten times less than traditional MRI units. Supported by top global venture capitalists, DeepSpin is expanding its Berlin team with a mission to make this vital technology accessible to billions.

Role Overview

As a Regulatory Affairs and Quality Assurance Specialist, you will manage and support the medical device certification process for our MRI system in both the US and European markets. You will also maintain and enhance our Quality Management System (QMS). This hands-on, impactful role requires collaboration with diverse teams to implement our regulatory strategies and help bring our pioneering product to market.

Key Responsibilities

• Coordinate and contribute to CE Class IIa medical device certification and FDA 510(k) submission package preparation.
• Create, review, and sustain technical documentation for regulatory submissions, including Design History Files, Device Master Records, Risk Management Files, and usability documentation compliant with IEC 62366.
• Support risk management activities per ISO 14971 and coordinate product testing related to electromagnetic safety, cybersecurity, and biocompatibility.
• Maintain and improve daily Quality Management System processes aligned with ISO 13485 and FDA 21 CFR 820 standards under leadership guidance.
• Perform gap analyses to identify compliance enhancements and collaborate with engineering on design reviews, SOPs, work instructions, and verification & validation testing.
• Serve as the main liaison with notified bodies such as TÜV, FDA, and LaGeSo, ensuring effective communication and coordination.
• Assist with post-market surveillance, vigilance, complaint handling, and establish a streamlined reporting infrastructure to meet regulatory requirements.

Candidate Profile

We seek a proactive and detail-focused regulatory professional who excels in teamwork and is motivated by supporting a sophisticated physical and digital medical device through its commercial lifecycle.

Essential Qualifications and Experience

• Degree in Life Sciences, Engineering, or a related technical discipline.
• Three to five years of direct regulatory experience in the medical device sector.
• Demonstrated track record with Class II medical device FDA 510(k) or CE certification processes.
• Well-versed in ISO 13485 and ISO 14971 standards, and experienced in coordinating testing for electromagnetic safety, cybersecurity, or biocompatibility.
• Proven ability to work directly with notified bodies and regulatory agencies.
• Strong written and spoken English communication skills.

Preferred Qualifications

• Risk Management training or experience following ISO 14971.
• Experience conducting clinical evaluations.
• Interest in the technical functioning of MRI technology.

Compensation and Benefits

• Competitive total compensation package of up to €110,000 annually, including a base salary between €70,000 and €80,000, benefits, and stock options.
• An innovative and cooperative workplace culture with flat hierarchies and transparent communication.
• A diverse international team working in an English-first environment representing over ten nationalities.
• Access to a penthouse office, company-sponsored meals, regular team activities, Urban Sports Club membership, public transportation subsidies, and lifestyle vouchers.
• Opportunities for growth via early responsibilities, internal mentoring, and support for external training or certifications.
• Thirty days of paid annual leave and flexible working schedules.
• Relocation assistance including visa support, moving logistics, and help locating local childcare options.