Quality Specialist
Quality & Regulatory Affairs Specialist - Medical Device Manufacturing (Sweden 🇸🇪)
Join a global leader in medical technology on a key manufacturing project in Sweden! We're seeking Quality & Regulatory Affairs Specialists to ensure compliance, product integrity, and adherence to international standards throughout the device lifecycle.
📍 Location: Sweden (Hybrid)
📅 Duration: 12-month contract
🚀 Start: ASAP
Your Role
- Oversee quality and compliance activities in alignment with ISO 13485, EU MDR, and global regulations.
- Support regulatory submissions, technical documentation, and audit readiness.
- Collaborate with cross-functional teams to maintain GMP standards and risk management processes.
- Act as a key point of contact for Notified Body interactions and internal quality reviews.
Key Requirements
✅ Proven experience in quality assurance and regulatory affairs within medical device manufacturing.
✅ Strong knowledge of ISO 13485, EU MDR, and familiarity with FDA 21 CFR Part 820.
✅ Understanding of infection prevention technologies, sterile reprocessing, and operating room solutions.
✅ Skilled in compliance oversight, technical documentation, and risk-based quality systems.
✅ Detail-oriented, proactive, and collaborative mindset.
📤 Interested? Send your CV and availability today - first batch of submissions goes out today!
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