Quality Assurance and Regulatory Affairs Associate
5 days ago
**What You Do?**
Quality Assurance
- Overall Maintenance of ISO 13485 Quality Management System, including Change Controls to ensure suitability for departments, and creation of new Quality Procedures as required
- Ensure all departments carry out due processes and documentation required to ensure all quality in all areas related to the medical device, such as design and development, production, and software
- Monitor and report on Quality Objectives and Key Performance Indicator, and recommend improvement on product quality/processes
- Management of non-conformances and corrective and preventive actions raised
- Implement and Oversee Annual Quality Calendar, which includes:
- Training Programme for continuous Education and Implementation of Quality Management in the Company
- Coordination, Planning and Conducting of Management Reviews and Internal Audits for departments
- Supporting third party audits activities including pre-audit planning, audit readiness, and post-audit follow up with external regulatory authorities
Regulatory Affairs
Key involvement in Regulatory Affairs activities, which includes:
- Strategise and Establish Regulatory Pathways to support Company's Commercial Routes
- Coordinate, Prepare and Lead Company for Regulatory Activities
- Conduct constant Regulatory Research and Surveillance
**What You Need?**
- Bachelor's Degree in Engineering, Science or related field
- Working knowledge of ISO 13485 Quality Management System preferred, and 21 CFR Part820 QSR is an advantage
- Experience in supporting/conducting Quality Audits is an advantage
- Familiarity and experience with the requirements for other medical device standards including biocompatibility, electrical safety, usability engineering, software lifecycle processes (i.e. ISO 14971, IEC 62304, etc.)
**Skills**
- Ability to work independently and cross-functionally with different teams
- Ability to speak and present both internally and externally on matters relating to QA and RA
- Strong research and analytical skills, and attention to detail
- Good verbal and written communication skills is essential
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