Chief Design Control Expert Medical Devices 17830
Veritaz ABPublicerad: 2026-05-21
Ansök senast: 2026-06-20
Beskrivning
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
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
