Chief Design Control Expert Medical Devices 17830

Veritaz AB  ·  Sverige  ·  Heltid  ·  💰 Fast och rörlig lön

Verifierad annons

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry. 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