Regulatory Affairs & Quality Assurance Specialist

About the role

As a Regulatory Affairs & Quality Assurance Specialist at DeepSpin, you will drive the certification of our innovative flat‑bed MRI system for the US and European markets. You will work closely with cross‑functional teams to ensure compliance, manage risk, and maintain a robust Quality Management System.

Key responsibilities

• Coordinate and contribute to CE Class IIa certification and FDA 510(k) submission packages.
• Draft, review, and maintain technical documentation such as Design History Files, Device Master Records, risk management files, and usability data (IEC 62366).
• Facilitate risk management activities according to ISO 14971 and support product testing for electromagnetic safety, cybersecurity, and biocompatibility.
• Maintain and continuously improve daily QMS processes in line with ISO 13485 and FDA 21 CFR 820.
• Conduct gap analyses, collaborate on design reviews, SOPs, work instructions, and V&V testing.
• Act as primary liaison with notified bodies (TÜV, FDA, LaGeSo) and competent authorities.
• Support post‑market surveillance, vigilance, and complaint handling, ensuring timely reporting under 21 CFR 803.

Required profile

• Proactive, detail‑oriented professional who thrives in a collaborative environment.
• Degree in Life Sciences, Engineering, or a related technical field.
• 3–5 years of hands‑on regulatory experience in the medical‑device industry.
• Proven success taking a Class II medical device through FDA 510(k) or CE certification.

Required skills

• CE Class IIa certification processes.
• FDA 510(k) submission preparation.
• Risk management per ISO 14971.
• Quality Management System implementation (ISO 13485, FDA 21 CFR 820).
• Usability engineering (IEC 62366).
• Electromagnetic safety, cybersecurity, and biocompatibility testing.
• Preparation of Design History Files and Device Master Records.