Assignment Description

We are currently looking for a Chief Design Expert

What You Will Work On

• Execute and maintain Design Control documentation across assigned product portfolios
• Manage and maintain documentation including DCTM, DHF, Design Inputs/Outputs, specifications, manufacturing descriptions, and justification reports
• Ensure document governance, version control, and audit readiness
• Drive post-approval change control execution, including impact assessments and closure activities
• Support implementation and documentation updates connected to approved Change Controls (CCs), deviations, and CAPAs
• Maintain and update Risk Management documentation aligned with ISO 14971
• Perform risk analyses and maintain risk management reports linked to manufacturing and lifecycle activities
• Provide documentation support and review for regulatory submissions and authority interactions
• Ensure consistency between design documentation and regulatory filings across EU MDR, US, and Canada
• Support execution of MDR-related projects and approval activities
• Contribute technical input to product submissions, manufacturing implementations, and verification initiatives
• Establish and maintain Life Cycle Management (LCM) documentation packages
• Ensure specifications remain robust, traceable, scientifically justified, and suitable for regulatory and manufacturing purposes

What You Bring

• Strong experience working with MDR-related design documentation and design control processes
• Proven experience maintaining and governing Design Control documentation in regulated environments
• Deep understanding of EU MDR and global regulatory expectations
• Experience managing post-approval changes, deviations, and CAPA-related documentation
• Strong experience with Risk Management processes aligned to ISO 14971
• Experience supporting regulatory submissions and authority interactions
• Knowledge of lifecycle management and maintaining compliant documentation structures
• Experience ensuring specification robustness, traceability, and technical justification
• Strong documentation, governance, and process management capabilities
• Ability to collaborate across regulatory, manufacturing, quality, and engineering functions
• Excellent communication skills with a structured and detail-oriented approach

If this sounds interesting please send your CV at cv@veritaz.se