
Regulatory Compliance Manager
5 days ago
We are looking for a highly skilled Regulatory Compliance Manager to join our team at Maxwill International.
The ideal candidate will have extensive knowledge of regulatory requirements and industry standards, as well as excellent communication and project management skills.
The key responsibilities of this role include:
- To ensure the quality management system is compliant with regulatory requirements.
- To develop and implement quality procedures, ensuring they are approved and effectively used by all staff members.
- To verify that measurement and inspection equipment is calibrated regularly to ensure product quality meets specified standards.
- To analyze quality control data on a periodic basis, identifying trends and areas for improvement.
- To manage the distribution and update of quality documents, preventing the reuse of obsolete materials.
- To initiate corrective actions when necessary, collaborating with other departments to address quality issues.
- To maintain records of calibration for quality control devices, adhering to established schedules.
- To participate in supplier evaluations and foster relationships with external organizations related to quality assurance.
- To lead internal audit teams, prepare annual audit plans, and ensure continuous communication of results.
- To promote occupational health and safety awareness among employees, ensuring adherence to relevant regulations.
- To take swift action to resolve non-compliance issues with medical devices and products supplied to the market.
The successful candidate will possess:
- A bachelor's degree in a relevant field.
- A minimum of 12 years of experience in quality management, with team leadership skills.
- Advanced English language proficiency (written and spoken).
- Familiarity with Microsoft Office and Logos software.
- Knowledge of MDR, MDD processes, and FDA regulations.
- Mastery of ISO 13485 certification processes.
- Strong analytical thinking, problem-solving, and time management skills.
This is an exciting opportunity for a motivated professional to join our team at Maxwill International.
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