Quality and Regulatory Manager
hace 7 días
As a Quality and Regulatory Manager, you will be responsible for overseeing the quality management system to ensure compliance with all regulations and continuously improving the quality of our services. This includes ensuring compliance with regulatory requirements for our products and services in the regions where we distribute them.
Key Responsibilities- Manage corporate quality management programs, including certification processes for ISO 14385
- Develop and drive continuous improvement to quality system processes through the development, execution, monitoring, and reporting of Quality Plans
- Undertake and manage regulatory inspections and audits, preparing, managing, and following up on audits to achieve continuous improvement of quality and processes
- Support the efficient and effective execution of the corrective action program, internal audit program, and other QMS subsystem elements, as well as the support of external audits and inspections
- Translate the strategy into quality in actual projects in the frame of generally accepted quality standards, including standards, GMP, GDP, etc., with the aim of achieving a continuous improvement
- Act as a qualified person with the aim of releasing products and analyses
- Keep up to date with national and international legislation and guidelines
- Continuously inform oneself about the latest trends in quality and keep one's knowledge up to date in function of new developments in this field
- Develop and implement processes with the aim of receiving approval for product and services
- Identify compliance issues that require follow up and conduct internal investigation of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues
- Maintaining regulatory documentation database
- Verify that all firm and regulatory policies and procedures have been documented and make sure every employee knows the applicable procedure and works accordingly
- Maintain good contact with authorities with the aim of anticipating changes or new developments and trends within the sector
- Plans and monitors training of people in the QMS and communicates the QMS system within the organization
Fagron is a trusted global company established in 1990, becoming a leading player in personalized medical solutions. With a talented team of over 2,000 professionals located in 34 countries, we proudly satisfy the needs of over 200,000 customers around the world.
We offer exciting opportunities for personal and professional growth in a dynamic environment that supports and encourages you to develop your skills and talents.
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