Senior Medical Device Quality & Regulatory Leader

Flow Neuroscience; Malmö kommun; Hybrid; SEK 900,000 - 1,200,000; Full time

Job summary

Flow Neuroscience is expanding its team with a Senior Medical Device Quality & Regulatory Engineer to own critical QA and regulatory infrastructure across the product lifecycle. The role collaborates with R&D, manufacturing, and supply chain to maintain DHFs, DHMs, and regulatory filings.

You will drive ISO 13485 QMS implementation, support EU MDR and FDA submissions, and prepare for inspections across global jurisdictions, in a hybrid setup between Sweden and the UK.

Qualifications

• Strong technical background in medical-device software or hardware/product engineering.
• Hands-on experience in medical-device design, development and manufacturing.
• Excellent ISO 13485 and FDA QMSR knowledge and implementation experience.
• Experience with FDA inspections and Notified Body audits.
• Proven ability to manage Technical Files / DHF / DMR and supplier quality control.

Responsibilities

• Lead and maintain Design Control processes (DHF, verification/validation, risk management, change control).
• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs.
• Drive supplier qualification, auditing, and ongoing manufacturing quality control improvements.
• Collaborate with R&D on design changes and process improvements.
• Support ISO 13485‑certified QMS and regulatory submissions (EU MDR, FDA).
• Ensure compliance with evolving regulations (FDA QMSR, EU/UK MDR).

Skills

Project management

Medical device hardware

Regulatory knowledge

Design controls ISO 13485

FDA QMSR experience

Supplier quality control

Technical Files / DHF / DMR

Regulatory submissions

Audits (FDA/Notified Bodies)

Job description

Flow Neuroscience is expanding its team with a Senior Medical Device Quality & Regulatory Engineer to own critical QA and regulatory infrastructure across the product lifecycle. The role collaborates with R&D, manufacturing, and supply chain to maintain DHFs, DHMs, and regulatory filings.

You will drive ISO 13485 QMS implementation, support EU MDR and FDA submissions, and prepare for inspections across global jurisdictions, in a hybrid setup between Sweden and the UK.