Day to Day –
Demonstrated knowledge in application and implementation of IVDR 2017/746 and ISO 13485.
Experience with DHF creation and maintenance and design control processes.
Assist in development and maintenance of records and procedures within the quality management system for regulatory compliance.
Participate in regulatory audits and certification inspection, helping to ensure operational compliance with established procedures.
Evaluate and interpret regulatory requirements and industry standards applicable to our operations.
Conduct comprehensive compliance assessment to identify gaps and areas of improvement.
Develop and implement compliance strategies and action plans to address any identified compliance gaps.
Monitor and facilitate the execution of compliance initiatives and projects.
Participate in and lead compliance and quality training programs to enhance site awareness and knowledge.
Support internal audit process to help ensure operational compliance with regulatory requirements is established and maintained by our procedures.
Continuously assess and enhance quality management system to align with evolving regulatory requirements and industry best practices.
Provide compliance related reports, analysis and feedback on the quality management system, leading indicators and KPIs.