Regulatory Affairs & Quality Assurance Manager (m/f/d) at DeepSpin

Berlin, , Germany -

Full Time

Start Date

Immediate

Expiry Date

09 Sep, 26

Salary

130000.0

Posted On

11 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Regulatory Affairs, Quality Assurance, FDA 510(k) Submission, CE Certification, ISO 13485, ISO 14971, QMS Management, Technical Documentation, Risk Management, Post-Market Surveillance, Medical Device Certification, Gap Analysis, V&V Testing, Compliance, Cybersecurity, Biocompatibility

Industry

Medical Equipment Manufacturing

Description

Your mission About DeepSpin Today, 7 out of 10 people globally lack access to life-saving Magnetic Resonance Imaging (MRI). Conventional MRI machines are massive, cost millions of euros, and require specialized, shielded rooms which means they are usually confined to large hospitals. At DeepSpin, we are changing that by building the World’s First Flatbed MRI. By rethinking MRI technology from the ground up, we have removed the traditional closed tube entirely. Our open-architecture scanner plugs into a standard wall socket, fits into regular doctor's offices, and costs 10x less than conventional systems. Backed by globally leading VCs, we are expanding our team in Berlin. This is an opportunity to join a mission-driven team bringing an essential medical technology to the billions of people who currently cannot afford it. Your profile About the Role As our Regulatory Affairs & Quality Assurance Manager, you will lead the medical device certification for our MRI system in the US and Europe, while managing and improving our Quality Management System (QMS). This is a key role where you will have direct ownership of our regulatory strategy and play a major part in bringing our product to market. Your Responsibilities: Certification: Drive the CE Class IIa medical device certification and FDA 510(k) submission processes. Documentation: Author, review, and maintain technical documentation for regulatory submissions; including Design History Files (DHF), Device Master Records (DMR), Risk Management Files, and usability data (IEC 62366). Compliance & Risk: Lead risk management activities according to ISO 14971, and manage product testing for electromagnetic safety/compatibility, cybersecurity, and biocompatibility. QMS Management: Define, implement, and continuously improve our QMS processes in line with ISO 13485 and FDA regulations. Gap Analysis & Technical Collaboration: Conduct gap analyses to identify areas needing improvement and implement corrective actions. Partner with engineering staff on design review meetings, SOPs, work instructions, and V&V testing. External Liaison: Act as the primary contact and coordinate with notified bodies (TÜV, FDA, LaGeSo) and competent authorities. Post-Market & Infrastructure: Support post-market surveillance, vigilance, and complaint handling (ensuring timely reporting under 21 CFR 803). Help build a simplified, practical reporting infrastructure that satisfies regulatory needs. About You You are an independent, self-organized regulatory professional who enjoys working across teams and wants the challenge of bringing a complex physical and digital product to market. What you bring: Education: A degree in Life Sciences, Engineering, or a related technical field. Experience: 7+ years of hands-on regulatory experience in the medical device industry. Track Record: Proven success taking a Class II medical device through the FDA 510(k) or CE certification process. Standards & Testing: Deep knowledge of ISO 13485 and experience managing product testing for electromagnetic safety, cybersecurity, and biocompatibility. Relationship Management: Experience engaging and working directly with notified bodies and authorities. Communication: Clear written and verbal communication skills in English. Nice-to-haves (Preferred): Accreditation as an auditor. Training or experience as a Risk Manager (ISO 14971). Experience with clinical evaluations. A technical interest in how MRI technology works. Why us? What We Offer Compensation: A total package value of up to €130,000/year (consisting of an €80,000 - €90,000 base salary + benefits+ stock options). Culture: A creative, collaborative workplace with flat hierarchies and open communication. International Team: An English-first office with over 10 different nationalities driven by the same purpose. Perks: Work from our penthouse office, enjoy company-sponsored lunches, regular team events, and access to Urban Sports Club, BVG (public transport), and lifestyle vouchers. Development: High responsibility from day one, internal mentorship, and support for external training or certifications. Balance: 30 days of paid annual leave and flexible working hours. Relocation: Support with visas, relocation logistics, and help finding local daycare for your children.

Responsibilities

Lead medical device certification for MRI systems in the US and Europe, specifically driving FDA 510(k) and CE Class IIa processes. Manage and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and FDA regulations.