Medtech QA/RA Specialist — Drive QMS & Compliance

Integration Diagnostics Sweden AB; Göteborgs kommun; On-site; SEK 550,000 - 850,000; Full time

Job summary

Integration Diagnostics Sweden AB is seeking a Quality Assurance/Regulatory Affairs Specialist (Medtech) to join a compact QA/RA team. You will support the QMS documentation, ensure compliance of Technical Documentation, and drive PMS activities under supervision.

The role emphasizes collaboration with QA/RA Manager, maintaining and improving QMS processes, and contributing to regulatory alignment for current and future product portfolios.

Qualifications

• Engineering or scientific degree; Medical Engineering or related field.
• Good knowledge about medical device development.
• Fluent in Swedish and English.

Responsibilities

• Manage document control activities to ensure quality and regulatory documentation is accurate, current, traceable and maintained in compliance with established procedures.
• Maintain Technical Documentation throughout the product lifecycle, ensuring documentation remains complete, current and aligned with product, process and regulatory changes.
• Support Change Management processes by coordinating documentation updates, tracking change actions and ensuring relevant quality and regulatory requirements are addressed.
• Support Post-Market Surveillance (PMS) activities, including collection, review and compilation of complaints, feedback, incidents, trend data and relevant literature.
• Assist in the investigation, documentation and follow-up of nonconformities, corrective and preventive actions (CAPAs), and effectiveness checks.
• Prepare, update and maintain procedures, work instructions, templates, records and other quality and regulatory documentation as assigned.
• Escalate identified compliance gaps, quality issues, documentation deficiencies and potential product safety concerns to designated company representatives.

Job description

Integration Diagnostics Sweden AB is seeking a Quality Assurance/Regulatory Affairs Specialist (Medtech) to join a compact QA/RA team. You will support the QMS documentation, ensure compliance of Technical Documentation, and drive PMS activities under supervision.

The role emphasizes collaboration with QA/RA Manager, maintaining and improving QMS processes, and contributing to regulatory alignment for current and future product portfolios.